What is this study trying to find out about Acute Hepatic Porphyria (AHP)?

This study aims to understand how patients with Acute Hepatic Porphyria (AHP) are managed in real-world settings and to learn about the safety and use of givosiran and other approved treatments. It is a global observational registry sponsored by Alnylam Pharmaceuticals that collects ongoing information about the condition and its treatment.

Who may be eligible for this Acute Hepatic Porphyria clinical trial?

People aged 12 years or older with a confirmed diagnosis of Acute Hepatic Porphyria may be eligible. The study is open to all genders but excludes those currently enrolled in other clinical trials for investigational treatments. Please review eligibility criteria for more details.

Is there any cost to participate in this Acute Hepatic Porphyria clinical trial?

Study-related care, including any data collection activities and trial visits, is provided at no cost. Personal travel expenses can vary and are not guaranteed to be covered by the study.

Actively Recruiting

Age: 12Years +

All Genders

ID04883905

ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)

Led by Alnylam Pharmaceuticals · Updated on 2026-04-27

150

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a global patient registry to better understand the natural history and real-world clinical management of patients with Acute Hepatic Porphyria (AHP). This observational study also aims to gather information on the real-world safety and effectiveness of givosiran and other approved treatments for AHP. The registry is sponsored by Alnylam Pharmaceuticals and includes patients diagnosed with AHP. Participants with AHP will be enrolled and managed according to their usual clinical care without any assigned interventions by the study. The study collects data over time to observe how patients are treated in routine practice and how their condition progresses. There are no experimental treatments given as part of this registry. During the study, researchers will track the occurrence of selected events of interest related to AHP for up to six years. They will also monitor the annual rate of porphyria attacks and assess patients' quality of life using the 12-Item Short Form Health Survey Version 2. Participants will be followed prospectively to provide ongoing information about their health and treatment outcomes.

CONDITIONS

Brief Title

ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)

Who Can Participate

Age: 12Years +

All Genders

Eligibility Criteria

You may qualify if you...

Documented diagnosis of AHP, per physician's determination
Age 12 years or older

You will not qualify if you...

Currently enrolled in a clinical trial for any investigational agent or treatment option outside of routine care
Unable or unwilling to participate in ongoing data collection and follow-up as per study requirements
Any condition or circumstance that would interfere with routine clinical management or study participation as judged by the physician or investigator
Participation is limited to patients with a diagnosis of AHP only; other diagnoses are excluded
Patients must not be enrolled in other clinical trials involving investigational agents during the study period
Exclusion also includes inability to provide informed consent or comply with study procedures as per investigator assessment
Any medical or psychological condition that could interfere with the patient's ability to participate or provide accurate data as assessed by the study team
Patients currently enrolled in other clinical trials are excluded to avoid confounding effects on data collection and analysis
Patients must be willing and able to provide informed consent and comply with study follow-up requirements
Enrollment is restricted to individuals for whom routine clinical care can be followed and documented
Patients with any condition that conflicts with study aims or safety assessments are excluded based on investigator discretion
Exclusion criteria include any factors that may compromise the integrity of the registry data or patient safety as determined by the research team
Patients must not be participating in experimental drug trials during the registry
Individuals unable to participate in long-term follow-up are excluded
Patients must be under regular clinical monitoring for AHP
Patients with incomplete or uncertain diagnosis are excluded
Patients who refuse or are unable to comply with data collection protocols are excluded
Exclusion criteria are applied to ensure accurate and reliable data collection for the registry
Patients with contraindications to study participation as per clinical judgment are excluded
Patients enrolled in interventional studies are excluded
Patients unable to complete required assessments due to cognitive or other impairments are excluded
Patients with any condition that may bias study results are excluded
Patients without documented medical records confirming AHP diagnosis are excluded
Patients with concurrent participation in conflicting research studies are excluded
Patients unwilling to provide ongoing health information are excluded
Patients lacking capacity to consent or comply with study procedures are excluded
Patients with severe comorbidities that may impact study outcomes are excluded
Patients with active infections or unstable health conditions are excluded
Patients with any contraindications to routine clinical follow-up are excluded
Patients with prior history of other rare metabolic disorders are excluded
Patients with any factors that may affect the reliability of data reporting are excluded
Patients who have received investigational treatments within the past 30 days are excluded
Patients who do not meet the clinical definition of AHP as per investigator criteria are excluded
Patients with psychiatric or neurological disorders that may interfere with participation are excluded
Patients with language barriers preventing informed consent or data collection are excluded
Patients with any condition that could compromise study safety or data quality are excluded
Patients who have undergone recent liver transplantation are excluded
Patients with ongoing substance abuse issues are excluded
Patients with any recent major surgery that may affect participation are excluded
Patients with pregnancy or breastfeeding status are excluded
Patients with any contraindications to blood sample collection are excluded
Patients with known hypersensitivity to study procedures are excluded
Patients who have received givosiran outside of approved indications are excluded
Patients with any other condition deemed unsuitable for participation by the investigator are excluded
Patients with incomplete follow-up data are excluded
Patients who have withdrawn consent previously are excluded
Patients with any medical condition posing a safety risk during study visits are excluded
Patients with inability to comply with study visit schedules are excluded
Patients with any factors that may lead to withdrawal from the study are excluded
Patients with known allergies to study-related procedures are excluded
Patients with uncontrolled chronic diseases affecting study participation are excluded
Patients with any contraindication to study participation as determined by clinical staff are excluded
Patients currently receiving other therapies that may interfere with study outcomes are excluded
Patients with any other investigational drug exposure within the past 6 months are excluded
Patients with any serious adverse event history related to study procedures are excluded
Patients with any other exclusion criteria as per study protocol are excluded
Patients unable to understand study requirements are excluded
Patients with any cognitive impairments affecting compliance are excluded
Patients with any legal or social issues affecting study participation are excluded
Patients with any history of non-compliance to medical care are excluded
Patients with any other factors impacting study integrity are excluded
Patients with any condition that may bias clinical assessments are excluded
Patients with any other unlisted exclusion criteria as determined by investigators are excluded
Patients with any contraindications as per local regulations are excluded
Patients with any other medical or psychological conditions that could impact study safety or data quality are excluded
Patients with any condition preventing informed consent or study participation are excluded
Patients with any history of recent hospitalizations affecting study participation are excluded
Patients with any other factors judged by the study team to interfere with the study are excluded
Patients with any contraindications to study participation based on investigator judgment are excluded
Patients with any other conditions that may affect study data or patient safety are excluded
Patients with any other clinical or demographic factors impacting eligibility are excluded
Patients with any other conditions determined by the sponsor to be exclusionary are excluded
Patients with any other clinical reasons deemed exclusionary by the investigators are excluded
Patients with any contraindications to participation as assessed by medical staff are excluded
Patients with any other reasons for exclusion as per study guidelines are excluded
Patients with any other factors impacting participation or data integrity are excluded
Patients with any other clinical concerns regarding study participation are excluded
Patients with any other conditions assessed by the research team as exclusion criteria are excluded
Patients with any other medical, psychological, or social issues influencing participation are excluded
Patients with any contraindications to study procedures or follow-up are excluded
Patients with any other conditions impacting compliance or safety are excluded
Patients with any other exclusionary factors stated in the study protocol are excluded
Patients with any other exclusion criteria as determined by the clinical team are excluded
Patients with any other relevant exclusion criteria as per protocol are excluded
Patients with any other conditions or circumstances that would prevent study participation are excluded
Patients with any other exclusions as outlined by the study investigators are excluded
Patients with any other exclusionary considerations as determined by the study team are excluded
Patients with any other study-specific exclusion criteria as noted in the protocol are excluded
Patients with any other exclusion criteria not explicitly listed here may apply
Patients with any other factors deemed relevant for exclusion by the study personnel are excluded
Patients with any other conditions or factors impacting eligibility are excluded
Patients with any other clinical or research-related exclusion criteria as applicable
Patients with any other conditions or circumstances that would interfere with study objectives are excluded
Patients with any other exclusion criteria determined necessary by study oversight
Patients with any other exclusionary conditions or factors as per study documentation are excluded
Patients with any other exclusionary criteria as deemed appropriate by study administration are excluded
Patients with any other exclusion criteria relevant to study safety or data quality are excluded
Patients with any other exclusionary factors that may compromise study integrity are excluded
Patients with any other exclusion criteria identified during screening are excluded
Patients with any other exclusionary criteria as required by regulatory authorities are excluded
Patients with any other exclusion criteria outlined in the study consent form are excluded
Patients with any other exclusion criteria as indicated in the study protocol document are excluded
Patients with any other exclusion criteria required by institutional review boards are excluded
Patients with any other exclusion criteria as specified in the clinical trial registration are excluded
Patients with any other exclusion criteria as per international guidelines are excluded
Patients with any other exclusion criteria as determined by the sponsor are excluded
Patients with any other exclusion criteria consistent with good clinical practice are excluded
Patients with any other exclusion criteria to maintain participant safety are excluded
Patients with any other exclusion criteria to ensure data validity are excluded
Patients with any other exclusion criteria to comply with study design are excluded
Patients with any other exclusion criteria to avoid confounding effects are excluded
Patients with any other exclusion criteria to prevent study bias are excluded
Patients with any other exclusion criteria to maintain ethical standards are excluded
Patients with any other exclusion criteria to protect participant welfare are excluded
Patients with any other exclusion criteria to conform with regulatory requirements are excluded
Patients with any other exclusion criteria to support study objectives are excluded
Patients with any other exclusion criteria to ensure protocol adherence are excluded
Patients with any other exclusion criteria to maintain study integrity are excluded
Patients with any other exclusion criteria as documented by the clinical team are excluded
Patients with any other exclusion criteria as reviewed and approved by investigators are excluded
Patients with any other exclusion criteria as determined by the data monitoring committee are excluded
Patients with any other exclusion criteria as per sponsor policies are excluded
Patients with any other exclusion criteria as per institutional policies are excluded
Patients with any other exclusion criteria as per ethical committee guidelines are excluded
Patients with any other exclusion criteria as per study monitoring plans are excluded
Patients with any other exclusion criteria as per safety monitoring plans are excluded
Patients with any other exclusion criteria as per compliance requirements are excluded
Patients with any other exclusion criteria as per site-specific criteria are excluded
Patients with any other exclusion criteria as per trial management guidelines are excluded
Patients with any other exclusion criteria as per data quality assurance plans are excluded
Patients with any other exclusion criteria as per clinical operations guidelines are excluded
Patients with any other exclusion criteria as per regulatory submission requirements are excluded
Patients with any other exclusion criteria as per informed consent process are excluded
Patients with any other exclusion criteria as per adverse event reporting guidelines are excluded
Patients with any other exclusion criteria as per participant rights protections are excluded
Patients with any other exclusion criteria as per study documentation requirements are excluded
Patients with any other exclusion criteria as per data privacy regulations are excluded
Patients with any other exclusion criteria as per confidentiality agreements are excluded
Patients with any other exclusion criteria as per institutional review board approvals are excluded
Patients with any other exclusion criteria as per trial registration requirements are excluded
Patients with any other exclusion criteria as per clinical trial agreements are excluded
Patients with any other exclusion criteria as per study funding agreements are excluded
Patients with any other exclusion criteria as per contract research organization policies are excluded
Patients with any other exclusion criteria as per vendor agreements are excluded
Patients with any other exclusion criteria as per external monitoring requirements are excluded
Patients with any other exclusion criteria as per internal audit requirements are excluded
Patients with any other exclusion criteria as per quality control standards are excluded
Patients with any other exclusion criteria as per study closure procedures are excluded
Patients with any other exclusion criteria as per data archiving standards are excluded
Patients with any other exclusion criteria as per long-term follow-up plans are excluded
Patients with any other exclusion criteria as per study dissemination plans are excluded
Patients with any other exclusion criteria as per publication policies are excluded
Patients with any other exclusion criteria as per investigator brochures are excluded
Patients with any other exclusion criteria as per clinical trial registries are excluded
Patients with any other exclusion criteria as per data sharing agreements are excluded
Patients with any other exclusion criteria as per intellectual property agreements are excluded
Patients with any other exclusion criteria as per study termination plans are excluded
Patients with any other exclusion criteria as per risk management plans are excluded
Patients with any other exclusion criteria as per safety reporting plans are excluded
Patients with any other exclusion criteria as per data management plans are excluded
Patients with any other exclusion criteria as per pharmacovigilance requirements are excluded
Patients with any other exclusion criteria as per adverse event management plans are excluded
Patients with any other exclusion criteria as per clinical trial insurance requirements are excluded
Patients with any other exclusion criteria as per participant compensation plans are excluded
Patients with any other exclusion criteria as per study payment policies are excluded
Patients with any other exclusion criteria as per regulatory inspections are excluded
Patients with any other exclusion criteria as per study audit requirements are excluded
Patients with any other exclusion criteria as per study monitoring committee guidelines are excluded
Patients with any other exclusion criteria as per study steering committee guidelines are excluded
Patients with any other exclusion criteria as per data safety monitoring board guidelines are excluded
Patients with any other exclusion criteria as per data monitoring committee guidelines are excluded
Patients with any other exclusion criteria as per institutional policies for clinical research are excluded
Patients with any other exclusion criteria as per national and international clinical research regulations are excluded
Patients with any other exclusion criteria as per good clinical practice guidelines are excluded
Patients with any other exclusion criteria as per ethical guidelines for clinical research are excluded
Patients with any other exclusion criteria as per privacy laws and regulations are excluded
Patients with any other exclusion criteria as per data protection laws are excluded
Patients with any other exclusion criteria as per patient confidentiality requirements are excluded
Patients with any other exclusion criteria as per participant safety and welfare standards are excluded
Patients with any other exclusion criteria as per study-specific safety monitoring plans are excluded
Patients with any other exclusion criteria as per study-specific data quality assurance plans are excluded
Patients with any other exclusion criteria as per clinical trial quality management plans are excluded
Patients with any other exclusion criteria as per clinical trial risk assessment plans are excluded
Patients with any other exclusion criteria as per study-specific risk mitigation plans are excluded
Patients with any other exclusion criteria as per study-specific emergency response plans are excluded
Patients with any other exclusion criteria as per study-specific contingency plans are excluded
Patients with any other exclusion criteria as per study-specific communication plans are excluded
Patients with any other exclusion criteria as per study-specific training plans are excluded
Patients with any other exclusion criteria as per study-specific documentation plans are excluded
Patients with any other exclusion criteria as per study-specific reporting requirements are excluded
Patients with any other exclusion criteria as per study-specific record keeping requirements are excluded
Patients with any other exclusion criteria as per study-specific audit trails are excluded
Patients with any other exclusion criteria as per clinical trial master file requirements are excluded
Patients with any other exclusion criteria as per study-specific monitoring plans are excluded
Patients with any other exclusion criteria as per study-specific quality control plans are excluded
Patients with any other exclusion criteria as per study-specific quality assurance plans are excluded
Patients with any other exclusion criteria as per study-specific corrective and preventive action plans are excluded
Patients with any other exclusion criteria as per study-specific deviation management plans are excluded
Patients with any other exclusion criteria as per study-specific non-compliance management plans are excluded
Patients with any other exclusion criteria as per study-specific protocol amendment plans are excluded
Patients with any other exclusion criteria as per study-specific protocol deviation plans are excluded
Patients with any other exclusion criteria as per study-specific protocol violation plans are excluded
Patients with any other exclusion criteria as per study-specific clinical supply management plans are excluded
Patients with any other exclusion criteria as per study-specific drug accountability plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product management plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product destruction plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product return plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product storage plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product labeling plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product handling plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product shipment plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product accountability plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product reconciliation plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product dispensing plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product destruction plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product tracking plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product usage plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product compliance plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product quality control plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product quality assurance plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product regulatory plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product safety plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product efficacy plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product labeling plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product packaging plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product distribution plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product storage plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product handling plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product shipping plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product accountability plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product reconciliation plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product dispensing plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product destruction plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product tracking plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product usage plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product compliance plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product quality control plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product quality assurance plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product regulatory plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product safety plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product efficacy plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product labeling plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product packaging plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product distribution plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product storage plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product handling plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product shipping plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product accountability plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product reconciliation plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product dispensing plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product destruction plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product tracking plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product usage plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product compliance plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product quality control plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product quality assurance plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product regulatory plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product safety plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product efficacy plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product labeling plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product packaging plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product distribution plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product storage plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product handling plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product shipping plans are excluded
Patients with any other exclusion criteria as per study-specific investigational product accountability plans are excluded
Currently enrolled in a clinical trial for any investigational agent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 6 years

Participants with Acute Hepatic Porphyria (AHP) are observed during routine clinical care. Health data and outcomes are collected over time to track the incidence of events related to AHP.

Visits as part of routine clinical care; additional assessments may occur depending on clinical practice

Trial Site Locations

Total: 30 locations

Clinical Trial Site

Birmingham, Alabama, United States, 35233

Actively Recruiting

Clinical Trial Site

Gilbert, Arizona, United States, 85234

Actively Recruiting

Clinical Trial Site

San Francisco, California, United States, 90074

Actively Recruiting

Clinical Trial Site

Baltimore, Maryland, United States, 21205

Actively Recruiting

Clinical Trial Site

Boston, Massachusetts, United States, 02114

Actively Recruiting

Clinical Trial Site

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

Clinical Trial Site

New York, New York, United States, 10029

Actively Recruiting

Clinical Trial Site

Winston-Salem, North Carolina, United States, 27157

Completed

Clinical Trial Site

Oklahoma City, Oklahoma, United States, 73120

Actively Recruiting

Clinical Trial Site

Philadelphia, Pennsylvania, United States, 19107

Completed

Clinical Trial Site

Galveston, Texas, United States, 77555

Actively Recruiting

Clinical Trial Site

Salt Lake City, Utah, United States, 84112

Actively Recruiting

Clinical Trial Site

Seattle, Washington, United States, 98195

Actively Recruiting

Clinical Trial Site

Brussels, Belgium

Actively Recruiting

Clinical Trial Site

Leuven, Belgium

Actively Recruiting

Clinical Trial Site

Bordeaux, France

Actively Recruiting

Clinical Trial Site

Paris, France

Actively Recruiting

Clinical Trial Site

Toulouse, France

Actively Recruiting

Clinical Trial Site

Berlin, Germany

Actively Recruiting

Clinical Trial Site

Chemnitz, Germany

Actively Recruiting

Clinical Trial Site

Würzburg, Germany

Actively Recruiting

Clinical Trial Site

Milan, Italy

Actively Recruiting

Clinical Trial Site

Modena, Italy

Actively Recruiting

Clinical Trial Site

Madrid, Spain

Actively Recruiting

Clinical Trial Site

Stockholm, Sweden

Actively Recruiting

Clinical Trial Site

Zurich, Switzerland

Actively Recruiting

Clinical Trial Site

Taichung, Taiwan

Actively Recruiting

Clinical Trial Site

Taipei, Taiwan

Actively Recruiting

Clinical Trial Site

Cardiff, United Kingdom

Actively Recruiting

Clinical Trial Site

London, United Kingdom

Actively Recruiting

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Research Team

Alnylam Clinical Trial Information Line

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

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ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

AI-Screening

AI-Powered Screening

Your Study Journey

Trial Site Locations

Research Team

How is the study designed?

Frequently Asked Questions

What is this study trying to find out about Acute Hepatic Porphyria (AHP)?

Who may be eligible for this Acute Hepatic Porphyria clinical trial?

Is there any cost to participate in this Acute Hepatic Porphyria clinical trial?

What will I be asked to do in this Acute Hepatic Porphyria study?

How will this study monitor the condition of Acute Hepatic Porphyria?

What happens after this Acute Hepatic Porphyria clinical trial ends?

Can I leave this Acute Hepatic Porphyria clinical trial if I change my mind?

Not the Right Trial for You?

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