Back to resultsSafety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis (MUSIC OL)
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Macitentan
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic pulmonary fibrosis, IPF, pulmonary fibrosis
Eligibility Criteria
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 (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:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Macitentan
Arm Description
Macitentan tablet, 10 mg, once daily
Outcomes
Primary Outcome Measures
Adverse Events leading to premature discontinuation of study drug
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01346930
Brief Title
Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
Acronym
MUSIC OL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Due to Protocol AC-055B201 (MUSIC) not meeting it's primary end point
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Actelion
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic pulmonary fibrosis, IPF, pulmonary fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Macitentan
Arm Type
Experimental
Arm Description
Macitentan tablet, 10 mg, once daily
Intervention Type
Drug
Intervention Name(s)
Macitentan
Intervention Description
10 mg, tablet, once daily
Primary Outcome Measure Information:
Title
Adverse Events leading to premature discontinuation of study drug
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 (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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loic Perchenet, PhD
Organizational Affiliation
Actelion
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
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