Status:
TERMINATED
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
Lead Sponsor:
Noorik Biopharmaceuticals AG
Conditions:
Cirrhosis
Portal Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Endothelin is a human hormone which has been associated with increased portal pressure in patients with liver cirrhosis (also called portal hypertension). Ambrisentan blocks the effects of endothelin....
Eligibility Criteria
Inclusion
- Signed informed consent including data protection declaration prior to study participation
- Subjects with confirmed cirrhosis (by biopsy, ultrasound, and/or laboratory examinations)
- Ascites Grade II or Grade III at screening currently treated with at least one diuretic or the subject is considered intolerant to diuretics in the investigator's opinion
Exclusion
- Age \<18 years of age
- Any of the following laboratory findings at the time of screening
- Serum creatinine level \>1.5mg/dL (\>132 µmol/L)
- Serum Na+ \< 125 meq/L
- Serum K+ ≥ 5.5 meq/L
- Serum bilirubin ≥ 5 mg/dL (85.5 µmol/L)
- INR \>3.0
- Women of childbearing potential with no effective contraceptive method (women of childbearing potential \[pre-menopausal, not surgically sterile for at least 3 months prior to the time of screening\] must have a confirmed negative serum β-hCG pregnancy test prior to enrolment and at Baseline Visit. They must use an effective contraceptive method throughout the study, and agree to repeat serum β-hCG pregnancy tests at designated visits)
- Pregnancy or lactation
- Systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg
- Sepsis and/or uncontrolled bacterial infection
- Current or recent documented nephrotoxicity (within 4 weeks)
- Hepatic Encephalopathy above grade 1
- History of variceal bleeding in the last 2 months
- Suspicion of active alcohol consumption in the last 3 months
- History of liver or kidney transplantation
- History of Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Suspected occlusive portal vein or splenic vein thrombosis
- Hepatocellular carcinoma (HCC) beyond the Milan criteria
- Acute Liver Failure or superimposed acute liver injury due to drugs (e.g., acetaminophen), dietary supplements, herbal preparations, viral hepatitis, or toxins
- Severe cardiovascular disease, including, but not limited to, unstable angina, pulmonary oedema, congestive heart failure
- Current or recent (within 30 days) renal replacement therapy (RRT)
- If on beta-blockers, a change in dose or drug within last 15 days prior to screening
- Use of any other endothelin receptor antagonist, octreotide, midodrine, terlipressin in last 15 days prior to screening
- Known hypersensitivity to contrast-media
- Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrains the assessment of efficacy
- Known sensitivity to ambrisentan or any of the excipients of the formulation
- Participation in other clinical research involving investigational medicinal products within 30 days of enrolment
- Subjects who have difficulties in understanding the language in which the study information is given
- Subjects who do not agree to the transmission of their anonymous data within the liability of documentation and notification
- Staff of the study centre, staff of the sponsor or Clinical Research Organization (CRO), the investigator himself or close relatives of the investigator.
- Cardiac and Pulmonary Haemodynamic Study exclusion Criteria: Subjects fulfilling any of the exclusion criteria below may participate in the study, but will not undergo cardiac and pulmonary catheterisation:
- Significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate \< 45 beats per minute or atrial fibrillation/flutter with sustained ventricular response of \> 90 beats per minute at rest, or Long QT syndrome or QTc \> 450 ms
- Significant left ventricular outflow tract obstructions (e.g., severe valvular aortic stenosis, obstructive cardiomyopathy), severe mitral stenosis, restrictive amyloid myocardiopathy, acute myocarditis
- Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated
- Major neurologic event including cerebrovascular events, within 30 days prior to screening
- Clinical evidence of acute coronary syndrome currently or within 30 days prior to screening
- Permanent pacemaker, cardiac resynchronisation device or implantable cardioverter-defibrillator in situ
Key Trial Info
Start Date :
April 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03827200
Start Date
April 11 2019
End Date
January 21 2021
Last Update
February 26 2021
Active Locations (6)
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1
Hospital Clinic Barcelona
Barcelona, Catalonia, Spain, 08036
2
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain, 28222
3
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041