Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT01346930
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2011-07-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Macitentan
Macitentan tablet, 10 mg, once daily
Macitentan
10 mg, tablet, once daily
Interventions
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Macitentan
10 mg, tablet, once daily
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Principal Investigators
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Loic Perchenet, PhD
Role: STUDY_CHAIR
Actelion
Other Identifiers
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AC-055B202
Identifier Type: -
Identifier Source: org_study_id
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