Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF) - Full Text View

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:

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:

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 ]
Idiopathic Pulmonary Fibrosis (IPF) acute exacerbation [ Time Frame: 3 years average ] [ Designated as safety issue: No ]
Physical examination (vital signs and weight) [ Time Frame: at 1year, 2 years, 3 years ] [ Designated as safety issue: No ]
Frequency of Adverse Events (AEs) [ Time Frame: at 1year, 2 years, 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	198
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2015
Estimated 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:

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.
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
Completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)

Exclusion criteria:

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.
Participation in another experimental clinical trial (except 1199.30) in the last 8 weeks.
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.
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).
Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc).
Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy.
Known or suspected active alcohol or drug abuse.
Patient not compliant in previous trial, with trial medication or trial visits.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170065

Show 61 Study Locations

Sponsors 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:	NCT01170065 History of Changes
Other Study ID Numbers:	1199.35, 2009-013788-21
Study First Received:	July 6, 2010
Last Updated:	May 15, 2013
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
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