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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	8 October 2021
Main ID:	EUCTR2007-001741-18-FR
Date of registration:	04/02/2008
Prospective Registration:	Yes
Primary sponsor:	Actelion Pharmaceuticals Ltd
Public title:	Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL
Scientific title:	Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL
Date of first enrolment:	24/06/2008
Target sample size:	390
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001741-18
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Austria	Belgium	Czech Republic	France	Germany	Ireland	Italy	Netherlands
Spain	United Kingdom

Contacts

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Address:
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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
•Before the release of the BUILD 3 results: Patients who have experienced a BUILD 3 protocol-defined event of IPF worsening and have had at least 1 year of double-blind treatment in BUILD 3.
•If BUILD 3 shows positive results: all patients who have completed BUILD 3 have the option of entering this OL study within 2 months after the last visit in BUILD 3.
•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.
•Patients should have completed all the assessments from the BUILD 3 EOS visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Any major violation of protocol AC-052-321 / BUILD 3.
•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.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1 Level: LLT Classification code 10021240 Term: Idiopathic pulmonary fibrosis

Intervention(s)

Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BOSENTAN
CAS Number: 147536978
Current Sponsor code: Ro 47-0203
Other descriptive name: Tracleer
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 62.5-

Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BOSENTAN
CAS Number: 147536978
Current Sponsor code: Ro 47-0203
Other descriptive name: Tracleer
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Main Objective: To assess long-term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).

Primary end point(s): N/A

Secondary Objective:

Secondary Outcome(s)

Secondary ID(s)

AC-052-322

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 24/06/2008
Contact:

Results

Results available:	Yes
Date Posted:	04/11/2016
Date Completed:	01/04/2010
URL:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001741-18/results

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