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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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT01346930
First received: May 2, 2011
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
 Drug: Macitentan
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Actelion:

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: 178
Study Start Date: July 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macitentan
Macitentan tablet, 10 mg, once daily
 Drug: Macitentan
10 mg, tablet, once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346930

Sponsors and Collaborators
Actelion
Investigators
Study Chair: Loic Perchenet, PhD Actelion
  More Information

No publications provided

Responsible Party: Sponsor, Actelion
ClinicalTrials.gov Identifier: NCT01346930     History of Changes
Other Study ID Numbers: AC-055B202
Study First Received: May 2, 2011
Last Updated: September 12, 2011
Health Authority: 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
IPF
pulmonary fibrosis

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 23, 2013