Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01170065
First received: July 6, 2010
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.

The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).

As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.


Condition Intervention Phase
Pulmonary Fibrosis
Drug: BIBF 1120
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Forced vital capacity decline [ Time Frame: 3 years average ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years average ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 3 years average ] [ Designated as safety issue: No ]
  • Diffusing capacity of the lung for carbon monoxide (DLco) decrease [ Time Frame: 3 years average ] [ Designated as safety issue: No ]
  • Frequency of Idiopathic Pulmonary Fibrosis (IPF) acute exacerbation [ Time Frame: 3 years average ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: at 1year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Frequency of Adverse Events (AEs), frequency of serious AE and AE that may lead to drug discontinuation [ Time Frame: at 1year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Time to first Idiopathic Pulmonary Fibrosis (IPF) acute exacerbation [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Vital signs (BP, PR) [ Time Frame: at 1year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at 1year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Clinically significant changes in liver transaminases (AST,ALT) [ Time Frame: at 1year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Clinically significant changes in gamma-GT [ Time Frame: at 1year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Clinically significant changes in alkaline phosphatase (PA) [ Time Frame: at 1year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • absolute and relative change from baseline in FVC values (mL and % predicted) [ Time Frame: 3 years average ] [ Designated as safety issue: No ]
  • Clinically significant changes in total bilirubin [ Time Frame: at 1 year, 2 years, 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: June 2010
Estimated Study Completion Date: June 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120 low qd
Low dose BIBF 1120 once daily
Drug: BIBF 1120
Low dose BIBF 1120 once daily
Experimental: BIBF 1120 low bid
Low dose BIBF 1120 twice daily
Drug: BIBF 1120
Low dose BIBF 1120 twice daily
Experimental: BIBF 1120 medium bid
Intermediate dose BIBF 1120 twice daily
Drug: BIBF 1120
Intermediate dose BIBF 1120 twice daily
Experimental: BIBF 1120 high bid
High dose BIBF 1120 twice daily
Drug: BIBF 1120
High dose BIBF 1120 twice daily

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patient with a primary diagnosis of IPF (according to the 2000 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria, who are willing to continue trial medication.
  2. Written informed consent signed prior to entry into the study, in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local law
  3. Completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)

Exclusion criteria:

  1. Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of trial 1199.30. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in 1199.30, if the investigator's benefit-risk assessment remains favourable.
  2. Participation in another experimental clinical trial (except 1199.30) in the last 8 weeks.
  3. Women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 10 weeks after end of active therapy.

    Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some Intra Uterine Devices (IUDs), sexual abstinence or vasectomized partner. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.

  4. Sexually active males not committing to using condoms during the course of the study and at least 10 weeks after the end of active therapy (except if their partner is not of childbearing potential).
  5. Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc).
  6. Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy.
  7. Known or suspected active alcohol or drug abuse.
  8. Patient not compliant in previous trial, with trial medication or trial visits.
  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: NCT01170065

  Show 63 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: NCT01170065     History of Changes
Other Study ID Numbers: 1199.35, 2009-013788-21
Study First Received: July 6, 2010
Last Updated: March 27, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Comision Nacional De Investigacion Cientifica y Tecnologica
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Central Committee Research Involving Human Subjects
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
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 October 29, 2014