Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00631475 | Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443 | PHASE3 | COMPLETED | 128 | — | — | Apr 1, 2008 | May 1, 2010 | Feb 4, 2025 | - | — |
| NCT00391443 | BUILD 3: Bosentan Use in Interstitial Lung Disease | PHASE3 | COMPLETED | 616 | — | — | Feb 1, 2007 | Jul 1, 2010 | Feb 4, 2025 | - | — |
| NCT00071461 | Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis | PHASE2 | COMPLETED | 158 | — | — | Aug 1, 2003 | May 1, 2010 | Feb 24, 2012 | 29 | United States, Canada +6 |
Mean extent of exposure to bosentan treatment in months
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
| Arm | Type | Description |
|---|---|---|
| 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 |
| Bosentan | EXPERIMENTAL | Subjects receive bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg b.i.d (if body weight \> 40 kg) or bosentan 62.5 mg b.i.d. (if body weight \< 40 kg) |
| Placebo | PLACEBO_COMPARATOR | Subjects receive placebo matching the bosentan treatment regimen |
| 2 | PLACEBO_COMPARATOR | Initial dose: 62.5 mg b.i.d. for 4 weeks. * Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated). * body weight \< 40 kg (90 lb): 62.5 mg b.i.d. |
| Name | Type | Description |
|---|---|---|
| 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.) |
| Placebo | DRUG | Placebo matching bosentan 62.5 mg tablets and 125 mg tablets |
Inclusion Criteria: Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of study (EOS) visit. * Signed informed consent prior to initiation of any study-related procedures. * Women of childbearing potential must have a negative serum pregnancy test and use reliabl...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP02, AP01 |
| MannKind Corporation | MNKD | 1 | PHASE1 | MNKD-201 |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE1 | NAL |
| AgomAb Therapeutics NV ADR | AGMB | 1 | PHASE1 | AGMB-447 |