Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 - Tabular View

Tracking Information

First Received Date ^ICMJE

February 12, 2008

Last Updated Date

October 14, 2009

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF) [ Time Frame: Start of study to end of study ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

There is no primary outcome measure for this OL study [ Time Frame: There is no primary outcome measure for this OL study ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00631475 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AE's leading to discontinuation of study drug [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
Treatment-emergent SAE's [ Time Frame: up to 28 days after the end of study drug ] [ Designated as safety issue: Yes ]
Occurrence of LFT (ALT and AST) abnormality [ Time Frame: up to 24 hours after the end of study treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3

Official Title ^ICMJE

Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321

Brief Summary

This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

Idiopathic Pulmonary Fibrosis

Intervention ^ICMJE

Drug: Bosentan

Study Arms / Comparison Groups

Experimental:

For patients who were administered bosentan during BUILD 3:

Same dose will continue

For patients who were administered placebo during BUILD 3:

Initial dose: 62.5 mg for 4 weeks Maintenance dose: 125 mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

600

Completion Date

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients should have completed all the assessments from the BUILD 3 EOS visit.

Signed informed consent prior to initiation of any study-related procedures.
Women of childbearing potential must have a negative serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination.

Exclusion Criteria:

Any major violation of protocol AC-052-321 / BUILD 3.
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 bosentan or any of the excipients.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Serbia, Spain, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00631475

Responsible Party

Sponsor, Actelion

Study ID Numbers ^ICMJE

AC-052-322

Study Sponsor ^ICMJE

Actelion

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Isabelle Leconte

Actelion

Information Provided By

Actelion

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP