Pulmonary Fibrosis Clinical Trial
Official title:
A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in
scarring of the lung and there is a high unmet medical need for effective treatment to halt
lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the
death rate.
In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of
treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function
of patients treated with high dose of BIBF 1120 compared to placebo.
Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of
BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial
will be conducted as a prospective, randomised design with the aim to collect safety and
efficacy data.
Respiratory function is globally accepted for assessment of treatment effects in IPF
patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is
part of the usual examinations done in IPF patients.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04638517 -
The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis
|
Phase 2 | |
| Recruiting |
NCT05299333 -
Comparison of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Post Covid Fibrosis
|
N/A | |
| Terminated |
NCT04119115 -
Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases
|
||
| Completed |
NCT01615484 -
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
|
N/A | |
| Completed |
NCT01417156 -
Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)
|
Phase 2 | |
| Terminated |
NCT00981747 -
Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis
|
Phase 2/Phase 3 | |
| Completed |
NCT00001596 -
Oral Pirfenidone for the Pulmonary Fibrosis of Hermansky-Pudlak Syndrome
|
Phase 2 | |
| Completed |
NCT00052052 -
An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)
|
Phase 2 | |
| Completed |
NCT01442779 -
Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
| Completed |
NCT00366509 -
Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
|
||
| Recruiting |
NCT00001532 -
Role of Genetic Factors in the Development of Lung Disease
|
||
| Recruiting |
NCT04767074 -
A Non-pharmacological Cough Control Therapy
|
N/A | |
| Recruiting |
NCT04864990 -
Dyspnea and Idiopathic Pulmonary Fibrosis
|
||
| Completed |
NCT01961362 -
Supplemental Oxygen in Pulmonary Fibrosis
|
||
| Completed |
NCT01271842 -
Long-term Outcome and Lung Capacity in Survivors of ARDS Due to Influenza A (H1N1) v2009 The RESPIFLU Study
|
N/A | |
| Completed |
NCT00650091 -
Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF
|
Phase 3 | |
| Active, not recruiting |
NCT00258544 -
Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF)
|
||
| Enrolling by invitation |
NCT04930289 -
Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
|
||
| Completed |
NCT02055222 -
Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease
|
||
| Enrolling by invitation |
NCT06327360 -
Illness Expectations in Pulmonary Fibrosis
|