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

Idiopathic Pulmonary Fibrosis Clinical Trial

— BUILD OL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631475
• Other study ID #: AC-052-322
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2008
• Last updated: September 9, 2015
• Start date: April 2008
• Est. completion date: May 2010

Study information

• Verified date: March 2015
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• 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.)

Locations

Country	Name	City	State
Australia	Prince Charles Hospital- Lung Transplant, Thoraic Dept.	Chermside	Queensland
Australia	St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine	Darlinghurst	New South Wales
Belgium	UZ Gasthuisberg	Leuven
Canada	Walter C. Mackenzie Health Sciences Centre-University of Alberta	Edmonton	Alberta
Canada	Lawson Health Research Institute	London	Ontario
Canada	The Health Care Corporation of St. John's-Eastern Health	St. John's	Newfoundland and Labrador
Canada	Institut de Cardiologie et de Pneumologie de l'Universite Laval	Ste-Foy	Quebec
Canada	Toronto General Hospital-Rosedale Medical Center PFT Lab	Toronto	Ontario
Czech Republic	University Hospital Na Bulovce	Praha 8
France	Hopital Avicenne	Bobigny
France	Hopital Louis Pradel	Bron
France	HYLAB, Clinique du Mail	Grenoble
Germany	HELIOS Klinikum Emil von Behring	Berlin
Germany	Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery	Coswig
Germany	Klinik Donaustauf-Zentrum für Pneumologie	Donaustauf
Germany	Ruhrlandklinik Pneumologie/Allergologie	Essen
Germany	Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin	Giessen
Germany	Lungenfachklinik Immenhausen; Pneumologische Lehrklinik der Universität Göttingen	Immenhausen
Germany	SKlinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern	Munich
Ireland	Mater Misicordiae University Hospital	Dublin
Israel	Hadassah medical Centrte: Ein Karem-Institue of Pulmonology	Jerusalem
Israel	Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergy Diseases	Tel-Aviv
Israel	Sheba Medical Centre-Pulmonology Institute	Tel-Hashomer
Italy	Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento	Forli
Italy	Pneumologia ISMETT	Palermo
Japan	Himeji medical center	Himeji	Hyogo
Japan	Kanagawa Cardiovascular Respiratory Center	Yokohama	Kanagawa
Korea, Republic of	Asan Medical Center	Seoul
Spain	Hospital Clinic Barcelona (Pneumology Service)	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital General de Valencia	Valencia
Switzerland	University Hospital Basel-Div of Pneumology	Basel
Switzerland	Inselspital Bern-Div of Pulmonary Medicine	Bern
Switzerland	University Hospital Zurich-Clinic for Pneumology & Lung Transplant Program	Zurich
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Papworth Hospital	Cambridgeshire
United Kingdom	Wythenshawe Hospital	Manchester
United States	Emory University	Atlanta	Georgia
United States	UAB Division of Pulmonary	Birmingham	Alabama
United States	Beth Israel Deaconness Medical Center	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	University of Cinicinnati	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Texas-Southwestern Dallas-Div of Pulm & Critical Care Unit	Dallas	Texas
United States	National Jewish Medical & Research Center	Denver	Colorado
United States	Inova Heart and Vascular Institute	Falls Church	Virginia
United States	Baylor College of Medicine	Houston	Texas
United States	UCLA- Division of Pulmonary & Critcal Care	Los Angeles	California
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Vanderbilt Medical Center- IPF Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	UCSD Medical Center	San Diego	California
United States	USCF-Interstitial Lung Disease Center	San Francisco	California
United States	Mayo Clinic	Scottsdale	Arizona
United States	University of Washington Medical Center	Seattle	Washington
United States	Pulmoary and Critical Care Medicine-Stanford University Medical Center	Stanford	California
United States	Wichita Clinic, P.A.	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)	Mean extent of exposure to bosentan treatment in months	Start of study to end of study, up to 21 months	Yes
Secondary	Number of Patients Exposed to Bosentan Over Time	Numbers of participants exposed to bosentan treatment over time	Start to end of study, up to 21 months	Yes
Secondary	Adverse Events (AE) Leading to Discontinuation of Study Drug.	Number of participants with at least one AE that led to permanent discontinuation of study treatment.	Start to end of study, up to 21 months	Yes
Secondary	Treatment-emergent Serious Adverse Events (SAE)	Number of participants with at least one SAE during the study.	up to 21 months plus 28 days after the end of study drug	Yes
Secondary	Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.	Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.	up to 21 months, plus 24 hours after the end of study treatment	Yes