Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | For patients who were administered bosentan during BUILD 3 (NCT00391443): Same dose will continue For patients who were administered placebo during BUILD 3 (NCT00391443): Initial dose: 62.5 mg for 4 weeks Maintenance dose: 125 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosentan | Drug | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adverse Events (AE) Leading to Discontinuation of Study Drug. |
Not provided
Inclusion Criteria:
Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of study (EOS) visit.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Isabelle Leconte | Actelion | Study Chair |
Not provided
In total, 128 of the 615 patients who received randomized treatment in BUILD 3 (NCT00391443) rolled over into the BUILD 3 OL extension.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 \ |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 \ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Mean extent of exposure to bosentan treatment in months | 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. | Posted | Mean | Standard Deviation | months | Start of study to end of study, up to 21 months |
|
|
Up to 28 days after the end of study drug
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 \ |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA (13.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Leconte, PhD/Data Science Group Leader, Director | Actelion Pharmaceuticals Ltd | + 41 61 565 64 18 | isabelle.leconte@actelion.com |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077300 | Bosentan |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
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 |
| 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 |
| 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 |
| Preparation for lung transplant |
|
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Patients Exposed to Bosentan Over Time | Numbers of participants exposed to bosentan treatment over time | 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. | Posted | Number | Participants | Start to end of study, up to 21 months |
|
|
|
| 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. | Study population | Posted | Number | participants | Start to end of study, up to 21 months |
|
|
|
| Secondary | Treatment-emergent Serious Adverse Events (SAE) | Number of participants with at least one SAE during the study. | Study population | Posted | Number | participants | up to 21 months plus 28 days after the end of study drug |
|
|
|
| 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. | Study population | Posted | Number | participants | up to 21 months, plus 24 hours after the end of study treatment |
|
|
|
| 51 |
| 128 |
| 5 |
| 128 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Blood iron decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Lung transplant | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| IDIOPATHIC PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (13.0) | Systematic Assessment |
|
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.
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| For at least 16 months |
|
| For at least 20 months |
|