Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis (MUSIC OL)

Actelion Pharmaceuticals

Status and phase

Withdrawn

Phase 2

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: Macitentan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01346930

AC-055B202

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.