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Trial record 95 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

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

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ClinicalTrials.gov Identifier: NCT00631475
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : August 3, 2012
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Intervention Drug: Bosentan
Enrollment 128
Recruitment Details 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 In total, 128 of the 615 patients who received randomized treatment in BUILD 3 (NCT00391443) rolled over into the BUILD 3 OL extension.
Arm/Group Title Bosentan Treatment
Hide Arm/Group Description 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
Period Title: Overall Study
Started 128
Completed 83
Not Completed 45
Reason Not Completed
Death             18
Adverse Event             14
Withdrew consent             5
Preparation for lung transplant             8
Arm/Group Title Bosentan Treatment
Hide Arm/Group Description 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
Overall Number of Baseline Participants 128
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants
65.4  (8.2)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 128 participants
18-40 years 1
41-60 years 33
61-70 years 62
>70 years 32
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
Female
31
  24.2%
Male
97
  75.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 128 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
1.Primary Outcome
Title Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Hide Description Mean extent of exposure to bosentan treatment in months
Time Frame Start of study to end of study, up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of open label (OL) treatment.
Arm/Group Title Bosentan Treatment
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: months
6.4  (4.6)
2.Secondary Outcome
Title Number of Patients Exposed to Bosentan Over Time
Hide Description Numbers of participants exposed to bosentan treatment over time
Time Frame Start to end of study, up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of OL treatment, respectively.
Arm/Group Title Bosentan Treatment
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 126
Measure Type: Number
Unit of Measure: Participants
For at least 4 months 74
For at least 8 months 44
For at least 12 months 17
For at least 16 months 7
For at least 20 months 2
3.Secondary Outcome
Title Adverse Events (AE) Leading to Discontinuation of Study Drug.
Hide Description Number of participants with at least one AE that led to permanent discontinuation of study treatment.
Time Frame Start to end of study, up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study population
Arm/Group Title Bosentan Treatment
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 128
Measure Type: Number
Unit of Measure: participants
32
4.Secondary Outcome
Title Treatment-emergent Serious Adverse Events (SAE)
Hide Description Number of participants with at least one SAE during the study.
Time Frame up to 21 months plus 28 days after the end of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Study population
Arm/Group Title Bosentan Treatment
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 128
Measure Type: Number
Unit of Measure: participants
51
5.Secondary Outcome
Title Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.
Hide Description Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.
Time Frame up to 21 months, plus 24 hours after the end of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Study population
Arm/Group Title Bosentan Treatment
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 128
Measure Type: Number
Unit of Measure: participants
3
Time Frame Up to 28 days after the end of study drug
Adverse Event Reporting Description Only adverse events leading to premature discontinuation of study treatment were reported during the study. All serious adverse events occurring during and up to 28 days after end-of-study treatment were reported. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
 
Arm/Group Title Bosentan Treatment
Hide Arm/Group Description 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
All-Cause Mortality
Bosentan Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bosentan Treatment
Affected / at Risk (%)
Total   51/128 (39.84%) 
Cardiac disorders   
Coronary artery disease  1  2/128 (1.56%) 
Arrhythmia  1  1/128 (0.78%) 
Atrial flutter  1  1/128 (0.78%) 
Cardiac arrest  1  1/128 (0.78%) 
Cardiopulmonary failure  1  1/128 (0.78%) 
Right ventricular failure  1  1/128 (0.78%) 
Gastrointestinal disorders   
Abdominal pain  1  1/128 (0.78%) 
Lower gastrointestinal haemorrhage  1  1/128 (0.78%) 
General disorders   
General physical health deterioration  1  1/128 (0.78%) 
Pyrexia  1  1/128 (0.78%) 
Hepatobiliary disorders   
Cholecystitis  1  1/128 (0.78%) 
Hepatic failure  1  1/128 (0.78%) 
Ischaemic hepatitis  1  1/128 (0.78%) 
Infections and infestations   
Lower respiratory tract infection  1  4/128 (3.13%) 
Pneumonia  1  4/128 (3.13%) 
Bronchitis  1  1/128 (0.78%) 
Chronic sinusitis  1  1/128 (0.78%) 
Diverticulitis  1  1/128 (0.78%) 
Lobar pneumonia  1  1/128 (0.78%) 
Respiratory tract infection viral  1  1/128 (0.78%) 
Septic shock  1  1/128 (0.78%) 
Sinusitis  1  1/128 (0.78%) 
Viral infection  1  1/128 (0.78%) 
Injury, poisoning and procedural complications   
Anastomotic stenosis  1  1/128 (0.78%) 
Rib fracture  1  1/128 (0.78%) 
Investigations   
Blood iron decreased  1  1/128 (0.78%) 
Hepatic enzyme increased  1  1/128 (0.78%) 
Liver function test abnormal  1  1/128 (0.78%) 
Nervous system disorders   
Cerebrovascular accident  1  1/128 (0.78%) 
Psychiatric disorders   
Suicide attempt  1  1/128 (0.78%) 
Renal and urinary disorders   
Renal colic  1  1/128 (0.78%) 
Renal failure acute  1  1/128 (0.78%) 
Respiratory, thoracic and mediastinal disorders   
Idiopathic pulmonary fibrosis  1  23/128 (17.97%) 
Respiratory failure  1  4/128 (3.13%) 
Dyspnoea  1  3/128 (2.34%) 
Acute respiratory failure  1  1/128 (0.78%) 
Pleuritic pain  1  1/128 (0.78%) 
Pneumothorax  1  1/128 (0.78%) 
Pulmonary oedema  1  1/128 (0.78%) 
Respiratory disorder  1  1/128 (0.78%) 
Surgical and medical procedures   
Lung transplant  1  3/128 (2.34%) 
Vascular disorders   
Deep vein thrombosis  1  1/128 (0.78%) 
Hypotension  1  1/128 (0.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bosentan Treatment
Affected / at Risk (%)
Total   5/128 (3.91%) 
General disorders   
OEDEMA PERIPHERAL  1  1/128 (0.78%) 
Investigations   
LIVER FUNCTION TEST ABNORMAL  1  2/128 (1.56%) 
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA  1  1/128 (0.78%) 
IDIOPATHIC PULMONARY FIBROSIS  1  1/128 (0.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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.
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.
Results Point of Contact
Name/Title: Isabelle Leconte, PhD/Data Science Group Leader, Director
Organization: Actelion Pharmaceuticals Ltd
Phone: + 41 61 565 64 18
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00631475     History of Changes
Other Study ID Numbers: AC-052-322
First Submitted: February 12, 2008
First Posted: March 7, 2008
Results First Submitted: June 19, 2012
Results First Posted: August 3, 2012
Last Update Posted: September 28, 2015