Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)

Launched by CIVI BIOPHARMA, INC. · Mar 6, 2019

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)