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

• Register: EUCTR
• Last refreshed on: 28 November 2016
• Main ID: EUCTR2009-013788-21-BE
• Date of registration: 08/03/2010
• Prospective Registration: Yes
• Primary sponsor: SCS Boehringer Ingelheim Comm.V
• Public 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
• Scientific 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
• Date of first enrolment: 22/04/2010
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013788-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patient with a primary diagnosis of IPF (according to 2000 ATS/ERS criteria), willing to continue trial medication
2. written informed consent prior to entry into the study, in accordance with ICH-GCP and local law
3. completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis
MedDRA version: 17.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: BIBF 1120
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
Current Sponsor code: BIBF 1120
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: BIBF 1120
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
Current Sponsor code: BIBF 1120
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: BIBF 1120
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
Current Sponsor code: BIBF 1120
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Main Objective: to establish the long term tolerability and safety profile of BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis in a roll-over study

Primary end point(s): The primary endpoint is Forced Vital Capacity decline (slope of decline between study entry and end of treatment)

Secondary Objective: effects of long trem treatment with BIBF 1120 on survival

Secondary ID(s)

1199.35

2009-013788-21-ES