Safety and Tolerability Study of Macitentan in Patients W... | NCT01346930

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

NCT01346930

Sponsor

Actelion

Status

Withdrawn

Last Update Posted

Jun 22, 2025Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Macitentan

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to Protocol AC-055B201 (MUSIC) not meeting it's primary end point

Expanded Access Info

Start Date

Jul 31, 2011Actual

Primary Completion Date

Aug 31, 2016Estimated

Completion Date

Aug 31, 2016Estimated

First Submitted Date

May 2, 2011

First Submission Date that Met QC Criteria

May 3, 2011

First Posted Date

May 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2025

Last Update Posted Date

Jun 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Macitentan	Experimental	Macitentan tablet, 10 mg, once daily	Drug: Macitentan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Macitentan	Drug	10 mg, tablet, once daily	Macitentan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events leading to premature discontinuation of study drug		5 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Loic Perchenet, PhD	Actelion	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D054990	Idiopathic Pulmonary Fibrosis
D011658	Pulmonary Fibrosis

Ancestor Terms

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D005355	Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided