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

History of Changes

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

Hide Participant Flow

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

Hide Baseline Characteristics

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

Show All Outcome Measures

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 ]

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

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 ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Actelion, with steering committee, shall complete the review and provide any modifications required to protect Actelion's patent rights and confidential information within sixty (60) days of receipt of the proposed publication. During this period, Investigator shall not permit publication. If Actelion reasonably anticipates filing a patent application claiming an invention arising out of the Study, such publication shall be delayed until after the application is filed.

Limitations and Caveats

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
No text entered.

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

To Top