Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01619085
First received: June 6, 2012
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
The aim of this extension trial is to provide BIBF 1120 treatment for all patients 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 may have experienced benefit from the drug and wish to continue treatment with BIBF 1120.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Pulmonary Fibrosis |
Drug: BIBF 1120 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF) |
Resource links provided by NLM:
Genetics Home Reference related topics:
idiopathic pulmonary fibrosis
MedlinePlus related topics:
Pulmonary Fibrosis
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- physical examination including vital signs & weight [ Time Frame: 312 weeks ] [ Designated as safety issue: Yes ]
- clinical laboratory tests (haematology& chemistry) [ Time Frame: 312 weeks ] [ Designated as safety issue: Yes ]
- Adverse events, serious adverse events, significant adverse events [ Time Frame: 312 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- absolute & relative change from baseline in FVC and in % predicted FVC [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
- on trial survival (all data collected based on fatal adverse events) [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
- time to first acute IPF exacerbation [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
- risk of acute IPF exacerbation [ Time Frame: 312 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 751 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BIBF 1120
patient to receive a capsule containing BIBF 1120 twice a day
|
Drug: BIBF 1120
BIBF 1120 BID (twice a day)
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
- Sexually active men not committing to using condoms during participation in the study (except if their partner is not of childbearing potential) and 3 months after the last intake of BIBF 1120.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619085
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Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Show 174 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01619085 History of Changes |
| Other Study ID Numbers: | 1199.33, 2011-002766-21 |
| Study First Received: | June 6, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Australia: Dept of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal and Health Products Canada: Health Canada Chile: Instituto de Salud Publica 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:
|
Fibrosis Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial |
ClinicalTrials.gov processed this record on May 16, 2013