Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01346930
• Date of registration: 02/05/2011
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis MUSIC OL
• Scientific 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
• Date of first enrolment: July 2011
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01346930
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Contacts

• Name: Loic Perchenet, PhD
• Affiliation: Actelion

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Macitentan

Primary Outcome(s)

Adverse Events leading to premature discontinuation of study drug [Time Frame: 5 years]

Secondary Outcome(s)

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]

Secondary ID(s)

AC-055B202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors