Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: June 6, 2012
Last updated: August 26, 2015
Last verified: August 2015
The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.
Idiopathic Pulmonary Fibrosis
Drug: BIBF 1120
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Primary Outcome Measures:
- incidence of overall adverse events [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- absolute & relative change from baseline in FVC and in % predicted FVC [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
- time to first acute IPF exacerbation [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
- time to death [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
- incidence of acute IPF exacerbation [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
- number of subjects with clinical relevant abnormalities in vital signs,physical examination including weight measurement or ECG parameters [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
- incidence of potentially clinically significant abnormalities in laboratory parameters [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2018 (Final data collection date for primary outcome measure)
Experimental: BIBF 1120
patient to receive a capsule containing BIBF 1120 twice a day
Drug: BIBF 1120
BIBF 1120 BID (twice a day)
|Ages Eligible for Study:
||40 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Signed Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practices (ICH-GCP) and local laws prior to trial participation.
- Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.5 fold Upper Limit of Normal (ULN) (Patients who completed the parent trial with transaminase values > 1.5 fold ULN but < 3 fold ULN are considered eligible)
- Bilirubin > 1.5 fold ULN
- Bleeding risk
- Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
- New major thrombo-embolic events developed after completion of the parent trial.
- Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.
- Usage of any investigational drug after completion of the parent trial or planned usage of a specific investigational drug during the course of this trial.
- A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patients' ability to participate in this trial.
- Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
- Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it until 3 months after end of treatment.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01619085
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 6, 2012
||August 26, 2015
||Australia: Dept of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Mexico: Ministry of Health
Netherlands: Central Committee Research Involving Human Subjects
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 03, 2015
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action