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

Sponsor:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00631475

Purpose

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).

Condition	Intervention	Phase
Idiopathic Pulmonary Fibrosis	Drug: Bosentan	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321

Resource links provided by NLM:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis

MedlinePlus related topics: Interstitial Lung Diseases Pulmonary Fibrosis

Drug Information available for: Bosentan

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	600
Study Start Date:	March 2008
Estimated Study Completion Date:	July 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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	Drug: Bosentan For patients who were administered Bosentan during BUILD 3: continue on same dose For patients who were administered placebo during BUILD 3: Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs < 90 lbs.) Other Name: Tracleer

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631475

Show 113 Study Locations

Sponsors and Collaborators

Actelion

Investigators

Study Chair:

Isabelle Leconte

Actelion

More Information

No publications provided

Responsible Party:	Sponsor, Actelion
ClinicalTrials.gov Identifier:	NCT00631475 History of Changes
Other Study ID Numbers:	AC-052-322
Study First Received:	February 12, 2008
Last Updated:	May 2, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Actelion:

bosentan
Tracleer
Actelion

BUILD 3
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease

Additional relevant MeSH terms:

Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias

Lung Diseases, Interstitial
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012