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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.

Official Title

A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension

Keywords

Portopulmonary Hypertension Macitentan

Eligibility

For people ages 18 years and up

Main Inclusion Criteria:

  • Male or female of at least 18 years of age
  • Confirmed diagnosis of portopulmonary hypertension

Main Exclusion Criteria:

  • Severe hepatic impairment
  • Severe obstructive or restrictive lung disease
  • Pulmonary veno-occlusive disease
  • Systolic blood pressure (SBP) < 90 mmHg at Screening
  • ALT/AST>= 3 x ULN
  • Bilirubin>= 3 mg/dL at Screening
  • Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results

Locations

  • UCSD accepting new patients
    La Jolla, California, 92037, USA
  • David Getten School of Medicine, UCLA accepting new patients
    Los Angeles, California, 90024, USA
  • USC accepting new patients
    Los Angeles, California, 90033, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Actelion
ID
NCT02382016
Phase
Phase 4
Study Type
Interventional
Last Updated
December 2016
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