Bosentan extension study for PAH pediatric patients

Phase 3

Conditions: Pulmonary arterial hypertension (PAH)

Registration Number: JPRN-jRCT2080222109

Lead Sponsor: Actelion Pharmaceuticals Japan Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Sex: All

Target Recruitment: 5

Inclusion Criteria

Patients who performed AC-052-377 study protocol.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

ACT-385781A extension study for PAH pediatric patients

Phase 3

Actelion Pharmaceuticals Japan Ltd.

Updated 10/17/2023

Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past

Phase 1

ITALFARMACO S.p.A.

Updated 8/28/2023

Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past

Phase 1

ITALFARMACO S.p.A.

Updated 9/15/2020

Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past

Phase 1

ITALFARMACO S.p.A.

Updated 3/4/2024

Study in which all the patients take the same investigational drug with theaim of evaluate the long-term safety, tolerability, and efficacy ofGIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophywho have been already treated in one of the GIVINOSTAT studies in thepast

Phase 1

ITALFARMACO S.p.A.

Updated 9/9/2024

Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past

Phase 1

ITALFARMACO S.p.A.

Updated 12/10/2019

Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies.

RecruitingPhase 3

CROMSOURCE BV

Updated 4/15/2024

Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past

Phase 1

ITALFARMACO S.p.A.

Updated 6/30/2019

An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2

Phase 1

Actelion Pharmaceuticals Ltd.

Updated 11/25/2019

An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2

Actelion Pharmaceuticals Ltd.

Updated 4/24/2012

Clinical Trial Alerts

Stay informed of key developments in this trial with timely notifications for researchers and healthcare professionals.

Enrollment status and site changes

Protocol modifications and amendments

Outcome data and publication updates

Clinical Trial Alerts

Stay informed of key developments in this trial with timely notifications for researchers and healthcare professionals.

Enrollment status and site changes

Protocol modifications and amendments

Outcome data and publication updates

Home Terms & Conditions Privacy Policy