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NCT Number: NCT00631475

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

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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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bosentan

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.)

Other names: Tracleer

Primary outcomes

  1. Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)

    Time frame: Start of study to end of study, up to 21 months

    Mean extent of exposure to bosentan treatment in months

Secondary outcomes

  1. Number of Patients Exposed to Bosentan Over Time

    Time frame: Start to end of study, up to 21 months

    Numbers of participants exposed to bosentan treatment over time

  2. Adverse Events (AE) Leading to Discontinuation of Study Drug.

    Time frame: Start to end of study, up to 21 months

    Number of participants with at least one AE that led to permanent discontinuation of study treatment.

  3. Treatment-emergent Serious Adverse Events (SAE)

    Time frame: up to 21 months plus 28 days after the end of study drug

    Number of participants with at least one SAE during the study.

  4. Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.

    Time frame: up to 21 months, plus 24 hours after the end of study treatment

    Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)

Acronym: BUILD OL

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 7, 2008
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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