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

Idiopathic Pulmonary Fibrosis Clinical Trial

— MUSIC OL  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01346930
• Other study ID #: AC-055B202
• Status: Withdrawn
• Phase: Phase 2
• First received: May 2, 2011
• Last updated: September 2, 2014
• Start date: July 2011
• Est. completion date: August 2016

Study information

• Verified date: September 2014
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health CanadaUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesSlovenia: Agency for Medicinal Products - Ministry of HealthSlovenia: Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesSouth Africa: Human Research Ethics CommitteeSouth Africa: Medicines Control CouncilTurkey: Ministry of HealthTurkey: Ethics CommitteeIsrael: Ethics CommissionIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ethics CommitteeSpain: Comité Ético de Investigación ClínicaSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Macitentan
10 mg, tablet, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events leading to premature discontinuation of study drug		5 years	Yes
Secondary	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		5 years	Yes