Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01619085
First received: June 6, 2012
Last updated: August 26, 2015
Last verified: August 2015
  Purpose

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.


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:


Further study details as provided by Boehringer Ingelheim:

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: 759
Study Start Date: June 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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:

  1. Signed Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practices (ICH-GCP) and local laws prior to trial participation.
  2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.

Exclusion criteria:

  1. 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)
  2. Bilirubin > 1.5 fold ULN
  3. Bleeding risk
  4. Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
  5. New major thrombo-embolic events developed after completion of the parent trial.
  6. Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.
  7. 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.
  8. 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.
  9. Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
  10. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619085

  Show 174 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01619085     History of Changes
Other Study ID Numbers: 1199.33, 2011-002766-21
Study First Received: June 6, 2012
Last Updated: August 26, 2015
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 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:
Fibrosis
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015