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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014