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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00631475
First received: February 12, 2008
Last updated: September 27, 2012
Last verified: September 2012
Results First Received: June 19, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Intervention: Drug: Bosentan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled at 61 centers in 15 countries (Australia, Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, South Korea, , Spain, Switzerland, UK, and USA. The first patient started on 5 March 2008 and the last patient, last visit was on 01 April 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 128 of the 615 patients who received randomized treatment in BUILD 3 (NCT00391443) rolled over into the BUILD 3 OL extension.

Reporting Groups
  Description
Bosentan Treatment Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter

Participant Flow:   Overall Study
    Bosentan Treatment  
STARTED     128  
COMPLETED     83  
NOT COMPLETED     45  
Death                 18  
Adverse Event                 14  
Withdrew consent                 5  
Preparation for lung transplant                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Bosentan Treatment Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter

Baseline Measures
    Bosentan Treatment  
Number of Participants  
[units: participants]
  128  
Age  
[units: years]
Mean ± Standard Deviation
  65.4  ± 8.2  
Age, Customized  
[units: participants]
 
18-40 years     1  
41-60 years     33  
61-70 years     62  
>70 years     32  
Gender  
[units: participants]
 
Female     31  
Male     97  
Region of Enrollment  
[units: participants]
 
Australia     12  
Belgium     1  
Canada     14  
Czech Republic     1  
France     3  
Germany     11  
Ireland     1  
Israel     4  
Italy     2  
Japan     8  
Korea, Republic of     5  
Spain     8  
Switzerland     4  
United Kingdom     3  
United States     51  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Number of Patients Exposed to Bosentan Over Time   [ Time Frame: Start to end of study, up to 21 months ]

3.  Secondary:   Adverse Events (AE) Leading to Discontinuation of Study Drug.   [ Time Frame: Start to end of study, up to 21 months ]

4.  Secondary:   Treatment-emergent Serious Adverse Events (SAE)   [ Time Frame: up to 21 months plus 28 days after the end of study drug ]

5.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Isabelle Leconte, PhD/Data Science Group Leader, Director
Organization: Actelion Pharmaceuticals Ltd
phone: + 41 61 565 64 18
e-mail: isabelle.leconte@actelion.com


No publications provided


Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00631475     History of Changes
Other Study ID Numbers: AC-052-322
Study First Received: February 12, 2008
Results First Received: June 19, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board