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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pulmonary Fibrosis

Treatments: Drug: BIBF 1120

Study type: Interventional

Funder types: Industry

Identifiers

NCT01170065

1199.35

2009-013788-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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198 participants in 4 patient groups

BIBF 1120 low qd

Experimental group

Description:

Low dose BIBF 1120 once daily

Treatment:

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120

BIBF 1120 low bid

Experimental group

Description:

Low dose BIBF 1120 twice daily

Treatment:

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120

BIBF 1120 medium bid

Experimental group

Description:

Intermediate dose BIBF 1120 twice daily

Treatment:

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120

BIBF 1120 high bid

Experimental group

Description:

High dose BIBF 1120 twice daily

Treatment:

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120

Drug: BIBF 1120