Status:
COMPLETED
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)
Lead Sponsor:
Civi Biopharma, Inc.
Conditions:
Raynaud Phenomenon Secondary to Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the effect of iloprost on the symptomatic relief of Raynaud's Phenomenon attacks in subjects with symptom...
Eligibility Criteria
Inclusion
- Male or female subjects must be greater than or equal to 18 years of age
- Subjects must have a diagnosis of Systemic Sclerosis
- Subjects must have a diagnosis or history of Raynaud's Phenomenon
- Subjects must have a minimum of 10 symptomatic Raynaud's Phenomenon attacks
- Female subjects of childbearing potential and male subjects must agree to use contraception for the duration of the study
- Subjects must be willing and able to comply with the study requirements and give informed consent for participation in the study
Exclusion
- Female subjects who are pregnant or breastfeeding
- Subjects with systolic blood pressure \<85 mmHg
- Subjects with an estimated glomerular filtration rate \<30 mL/min/1.73 m2
- Subjects with Child-Pugh Class B or Class C liver disease or an alanine aminotransferase and/or aspartate aminotransferase value \>3 × the upper limit of normal at screening.
- Subjects with gangrene, digital ulcer infection, or requirement of cervical or digital sympathectomy
- Subjects with intractable diarrhea or vomiting
- Subjects with a risk of clinically significant bleeding events including those with coagulation or platelet disorders
- Subjects with a history of major trauma or hemorrhage
- Subjects with clinically significant chronic intermittent bleeding such as active gastric antral vascular ectasia or active peptic ulcer disease
- Subjects who have had any cerebrovascular events
- Subjects with a history of myocardial infarction or unstable angina within 6 months of screening
- Subjects with acute or chronic congestive heart failure
- Subjects with a history of life-threatening cardiac arrhythmias
- Subjects with a history of hemodynamically significant aortic or mitral valve disease
- Subjects with more than mild restrictive or congestive cardiomyopathy uncontrolled by medication or implanted device.
- Subjects with known pulmonary hypertension, pulmonary arterial hypertension, or pulmonary veno-occlusive disease
- Subjects with a history of significant restrictive lung disease defined as forced vital capacity \<45% predicted and diffusing capacity of the lungs for carbon monoxide \<40% predicted (uncorrected for hemoglobin).
- Subjects with a history of cervical or digital sympathectomy
- Subjects with scleroderma renal crisis
- Subjects with a concomitant life-threatening disease with a life expectancy \<12 months
- Subjects who have a clinically significant disorder, that in the opinion of the Investigator, could contraindicate the administration of study drug, affect compliance, interfere with study evaluations, or confound the interpretation of study results
- Subjects who have taken or are currently taking any parenteral, inhaled, or oral prostacyclin or prostacyclin receptor agonists
- Subjects must not initiate dosing of oral, topical, or intravenous (IV) vasodilators or if currently receiving any vasodilator must have been stably medicated
- Subjects with any history of acetaminophen intolerability
- Subjects with any malignancy that requires treatment during the study period, that has required treatment within 1 year of screening, or that is currently not in remission.
- Subjects who have used any investigational medication or device for any indication within 30 days or 5 half-lives (whichever is longer)
Key Trial Info
Start Date :
March 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03867097
Start Date
March 7 2019
End Date
August 6 2019
Last Update
May 25 2025
Active Locations (16)
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1
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States, 85032
2
Pacific Arthritis Care Center of Los Angeles
Los Angeles, California, United States, 90045
3
Stanford University Medical Center
Palo Alto, California, United States, 94305
4
University of California San Francisco
San Francisco, California, United States, 94143