Table 2.
Ongoing clinical trials in pulmonary fibrosis.
| Title: description | Phase | Primary outcomes measure | Trial duration | ClinicalTrials.gov ID |
|---|---|---|---|---|
| Bosentan in PH in ILD Treatment Study: aims to determine the ability of bosentan to reduce PH in patients with scarring (fibrosing) lung disease | 4 | Fall in PVR of 20% over 16 wks | 4/30/2008 to 8/31/2010 | NCT00637065 |
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| Treprostinil Therapy for Pts with ILD and Severe PAH: the hypothesis is that IV or SC treprostinil can improve 6MWD, hemodynamics and QOL in pts with ILD and severe secondary PAH | 3 | 6MWD | 1/31/2008 to 2/28/2009 | NCT00705133 |
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| PAH Secondary to IPF and Treatment with Sildenafil: evaluates whether sildenafil improves morbidity and mortality in the peri-lung transplant setting in both IPF cohorts with either resting or exercise PAH | 4 | 6MWD | 2/28/2007 to 2/31/2009 | NCT00625079 |
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| Pilot Study of a Multi-Drug Regimen for Severe PF in HPS: evaluates if pravastatin, losartan, zileuton, N-acetylcysteine, and erythromycin used together can slow the course of PF in pts with HPS | 1/2 | Survival | 4/30/2007 to (date n/a) | NCT00467831 |
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| A Study to Evaluate the Safety and Effectiveness of CNTO-888 Administered IV in Subjects with IPF: evaluates safety and efficacy of CNTO-888 | 2 | Pulmonary function and safety | 12/31/2008 to 6/30/2012 | NCT00786201 |
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| Losartan in Treating Pts with IPF: evaluates the safety and efficacy of losartan | n/a | FVC | 3/31/2009 to (date n/a) | NCT00786201 |
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| Losartan in Treating PF Caused by Radiation Therapy in Pts with Stage I, II, or III NSCLC: evaluates the efficacy of losartan in this pt population | n/a | Change in carbon monoxide diffusing capacity | 5/31/2009 to (date n/a) | NCT00880386 |
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| Trial of Iloprost in PH Secondary to PF: evaluates safety and efficacy of iloprost | 3 | Safety; pulmonary arterial pressure; 6MWT | 3/31/2007 to 8/31/2007 | NCT00439543 |
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| Targeting Vascular Reactivity in IPF: evaluates if combination therapy with N-acetylcysteine, sildenafil, and losartan can improve function and exercise tolerance in pts with IPF | 2/3 | A 6MWT; QOL score | 9/30/2009 to 7/31/2013 | NCT00981747 |
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| Pomalidomide for Cough in Pts With IPF: evaluates the safety and efficacy of pomalidomide over a 12-week duration in the treatment of chronic cough in pts with IPF | 2 | Cough-related QOL | 7/31/2010 to 7/31/2013 | NCT01135199 |
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| Trial of IW-001 in Pts with IPF: an open-label, multicenter study designed to explore the biological and clinical effects of IW-001 | 1 | Safety and tolerability | 9/30/2010 to 9/30/2011 | NCT01199887 |
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| A Study to Characterize the Safety, PK and Biological Activity of CC-930 in IPF: evaluates the safety and PK profile of CC-930 | 2 | Safety and PK | 1/31/2011 to 1/30/2013 | NCT01203943 |
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| Safety and PK Study with AB-0024 in Pts with IPF: this dose-escalation study evaluates the safety, tolerability, PKs, and pharmacodynamics of AB-0024 | 1 | Safety and PK | 12/31/2010 to/31/2012 | NCT01242189 |
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| A Study of the Safety, Tolerability, PKs, and Pharmacodynamics of IV PRM-151 in Pts with IPF: this study includes multiple doses of IV PRM-151 | 1b | Safety and tolerability | 1/31/2011 to 8/31/2011 | NCT01254409 |
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| Safety, Tolerability, and Efficacy Study of IPF: evaluates the safety and tolerability of FG-3019 in pts with IPF and the efficacy of FG-3019 for attenuating fibrosis in these pts | 2a | Safety and tolerability | 12/31/2010 to 12/31/2012 | NCT01262001 |
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| Safety and Efficacy of QAX-576 in Pts with Progressive IPF: designed to evaluate the safety, tolerability, PKs and efficacy of QAX-576 in pts with rapidly progressive IPF | 2 | Safety, tolerability, and effect on lung function | 12/31/2010 to (date n/a) | NCT01266135 |
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| Combined PEX, Rituximab (a chimeric MAb against the protein CD20) and Steroids in Acute IPF Exacerbations: an open-label trial to compare combined plasma exchange, rituximab, and conventional corticosteroid administration on the outcomes of hospitalized pts | 1/2 | Feasibility and safety | 3/31/2011 to (date n/a) | NCT01266317 |
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| Safety and Efficacy of BIBF-1120 at High-Dose in IPF Pts:. a prospective, randomized trial that compares BIBF-1120 with placebo | 3 | Annual rate of decline in FVC | 4/30/2011 to 1/31/2014 | NCT01335464 |
PH: pulmonary hypertension. ILD: interstitial lung disease. PVR: pulmonary vascular resistance. IPF: idiopathic pulmonary fibrosis. PAH: pulmonary arterial hypertension. 6MWD: six-minute walk distance. QOL: quality of life. PF: pulmonary fibrosis. n/a: not available. HPS: Hermansky-Pudlak syndrome. FVC: forced vital capacity. NSCLC: non-small cell lung cancer. 6MWT: 6-minute walk test. PK: pharmacokinetic. PEX: plasma exchange. MAb: monoclonal antibody.