Study to evaluate if macitentan is safe and tolerable enough to be usedfor treatment of idiopathic pulmonary fibrosis, following the MUSICstudy

Phase 1

• Conditions: Patients with Idiopathic Pulmonary Fibrosis; MedDRA version: 14.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-024211-13-ES
• Lead Sponsor: ACTELION Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-10
• Study Completion: 2012-02-17
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

- Signed informed consent prior to initiation of any study-related
procedure.
- Patients with IPF and having completed the double-blind AC-
055B201/MUSIC study as scheduled, i.e., having remained in the study
until the sponsor-declared end-of study, whether or not study treatment
was prematurely discontinued.
- Women of childbearing potential must have a negative pre-treatment
serum pregnancy test and must use a reliable method of contraception
during study treatment and for at least 28 days after study treatment
termination.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 113

Exclusion Criteria

- Any major violation of protocol AC-055B201/MUSIC.
- Premature discontinuation of study treatment during the AC-
055B201/MUSIC study due to an adverse event (AE) assessed as related
to the use of macitentan, excluding events of IPF worsening.
- Pregnancy or breast-feeding.
- AST and/or ALT > 3 times the upper limit of the normal range.
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug
or alcohol dependence or psychiatric disease.
- Known hypersensitivity to drugs of the same class as macitentan, or
any of the excipients.

Study & Design

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