Study of a new therapeutic agent used to treat portopulmonary hypertensio

Phase 1

• Conditions: Portopulmonary hypertension; MedDRA version: 20.0Level: PTClassification code 10067281Term: Portopulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004624-21-CZ
• Lead Sponsor: ACTELION Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1) Male or female 18 years of age with symptomatic PoPH:
Documented diagnosis of portal hypertension
PAH by right-heart catheterization at screening
- Mean pulmonary arterial pressure (mPAP) = 25 mmHg
- Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) = 15 mmHg
2) Pulmonary vascular resistance (PVR) = 4 Wood Units or = 320 dyn.s.cm-5 at screening
3) 6MWD = 50 m at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Severe hepatic impairment, as defined by Child-Pugh Class C liver disease or MELD score = 19
2. Systolic blood pressure (SBP) < 90 mmHg at Screening
3. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 3 X the upper limit of the normal range (ULN) at Screening
4. Bilirubin = 3 mg/dL at Screening
5. Grades 2, 3, or 4 hepatic encephalopathy
6. History of liver transplantation
7. Gastrointestinal bleeding or esophageal varices bleeding < 3 months prior to randomization
8. Treatment with calcium channel blockers, and endothelin receptor antagonist (ERA), i.v./s.c. or oral prostanoids within 3 months prior to randomization
9. Treatment with interferon within 3 months prior to randomization
10. Treatment with strong cytochrome P450 (CYP) 3A4 inducers within 4 weeks prior to randomization
11. Treatment with strong CYP3A4 inhibitors within 4 weeks prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified