Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study

• Register: EUCTR
• Last refreshed on: 19 April 2022
• Main ID: EUCTR2010-024211-13-SE
• Date of registration: 05/04/2011
• Prospective Registration: Yes
• Primary sponsor: ACTELION Pharmaceuticals Ltd.
• Public title: Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study
• Scientific 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 - MUSIC OL
• Date of first enrolment: 26/05/2011
• Target sample size: 178
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024211-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, Germany, Israel, Slovenia, South Africa, Spain, Sweden, Turkey, United States

Contacts

• Name: Global Medical Information
• Affiliation: ACTELION Pharmaceuticals Ltd.

• Name: Global Medical Information
• Affiliation: ACTELION Pharmaceuticals Ltd.

Key inclusion & exclusion 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, 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 113

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Patients with Idiopathic Pulmonary Fibrosis
MedDRA version: 13.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: Macitentan
Product Code: ACT-064992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: macitentan
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: To assess the long-term safety and tolerability of macitentan in patients with Idiopathic Pulmonary Fibrosis

Primary end point(s): - AEs leading to premature discontinuation of study drug.
- Treatment-emergent SAEs up to 28 days after study drug discontinuation.
- Occurrence of liver aminotransferase (ALT and/or AST) abnormality (> 3 and < or = 5 X ULN; > 5 and < or = 8 X ULN; > 8 X ULN) up to 28 days after study drug discontinuation.

Secondary Objective: N/A

Timepoint(s) of evaluation of this end point: - 6-monthly safety visit
- Liver aminotransferase and pregnancy (if applicable): monthly
- Follow-up period 28 days after treatment discontinuation

Secondary Outcome(s)

Secondary end point(s): NA

Timepoint(s) of evaluation of this end point: NA

Secondary ID(s)

AC-055B202

Source(s) of Monetary Support

ACTELION Pharmaceuticals Ltd.

Ethics review

Status: Approved
Approval date: 25/05/2011
Contact:

Results

• Results available: Yes
• Date Posted: 26/10/2018
• Date Completed: 17/02/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-024211-13/results