Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis (MUSIC OL)
This study has been withdrawn prior to enrollment.
(Due to Protocol AC-055B201 (MUSIC) not meeting it's primary end point)
Information provided by:
First received: May 2, 2011
Last updated: September 12, 2011
Last verified: September 2011
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).
Idiopathic Pulmonary Fibrosis
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Adverse Events leading to premature discontinuation of study drug [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2016 (Final data collection date for primary outcome measure)
Macitentan tablet, 10 mg, once daily
10 mg, tablet, once daily
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346930
||Loic Perchenet, PhD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 2, 2011
||September 12, 2011
||Canada: Ethics Review Committee
Canada: Health Canada
United States: Food and Drug Administration
United States: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
Turkey: Ministry of Health
Turkey: Ethics Committee
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Keywords provided by Actelion:
Idiopathic pulmonary fibrosis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Idiopathic Pulmonary Fibrosis
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial