Study Stopped
Due to Protocol AC-055B201 (MUSIC) not meeting it's primary end point
Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
MUSIC OL
Long Term, Single-arm, Open-label Extension Study of the MUSIC Study to Assess the Safety and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The MUSIC OL study is an open-label extension study, in which all eligible patients having completed the double-blind AC-055B201/MUSIC study as scheduled receive macitentan 10 mg once daily. The study objective is to assess the long-term safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis (IPF).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2011
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedStudy Start
First participant enrolled
July 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2016
CompletedJune 22, 2025
June 1, 2025
5.1 years
May 2, 2011
June 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events leading to premature discontinuation of study drug
5 years
Secondary Outcomes (1)
Treatment-emergent Severe Adverse Events & occurrence of AST and/or ALT > 3 times the upper limit of the normal range up to 28 days after study drug discontinuation
5 years
Study Arms (1)
Macitentan
EXPERIMENTALMacitentan tablet, 10 mg, once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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 (EOS), 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Loic Perchenet, PhD
Actelion
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2011
First Posted
May 4, 2011
Study Start
July 31, 2011
Primary Completion
August 31, 2016
Study Completion
August 31, 2016
Last Updated
June 22, 2025
Record last verified: 2025-06