Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-05-31

Brief Summary

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This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

For patients who were administered bosentan during BUILD 3 (NCT00391443):

Same dose will continue

For patients who were administered placebo during BUILD 3 (NCT00391443):

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

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

For patients who were administered Bosentan during BUILD 3 (NCT00391443):

continue on same dose

For patients who were administered placebo during BUILD 3 (NCT00391443):

Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs \< 90 lbs.)

Interventions

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Bosentan

For patients who were administered Bosentan during BUILD 3 (NCT00391443):

continue on same dose

For patients who were administered placebo during BUILD 3 (NCT00391443):

Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs \< 90 lbs.)

Intervention Type DRUG

Other Intervention Names

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Tracleer

Eligibility Criteria

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Inclusion Criteria

Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of study (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 (NCT00391443).
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No