Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study

Phase 1

• Conditions: Patients with Idiopathic Pulmonary Fibrosis; MedDRA version: 13.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-05
• 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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: N/A;Main Objective: To assess the long-term safety and tolerability of macitentan in patients with Idiopathic Pulmonary Fibrosis;Primary end point(s): - AEs leading to premature discontinuation of study drug.<br>- Treatment-emergent SAEs up to 28 days after study drug discontinuation.<br>- Occurrence of liver aminotransferase (ALT and/or AST) abnormality (> 3 and < or = 5 X ULN; > 5 and < or = 8 X ULN; > 8 X ULN) up to 28 days after study drug discontinuation.;Timepoint(s) of evaluation of this end point: - 6-monthly safety visit <br>- Liver aminotransferase and pregnancy (if applicable): monthly <br>- Follow-up period 28 days after treatment discontinuation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA