A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF

• Register: EUCTR
• Last refreshed on: 11 February 2013
• Main ID: EUCTR2006-002875-42-DE
• Date of registration: 08/05/2007
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF
• Scientific title: A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF
• Date of first enrolment: 06/07/2007
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002875-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

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

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patient =40 years
2. Written informed consent signed prior to entry into the study
3. IPF diagnosed (according to ATS / ERS criteria) less than 5 years prior to screening visit.
4. HRCT within 12 months of randomisation and biopsy (the latter if needed to fulfil ATS/ERS criteria) centrally reviewed and consistent with diagnosis.
5. FVC =50 % of predicted value
6. Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted .
7. PaO2 =55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air

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. AST, ALT > 1.5 x ULN at screening
2. Bilirubin > 1.5 x ULN at screening
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7) at screening
4. Continuous oxygen supplementation at randomisation (defined as = 15 hours supplemental oxygen per day).
5. Active infection at screening or randomisation.
6. Neutrophils < 1500 / mm3 at screening
7. International normalised ratio (INR) > 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN at screening
8. Platelets < 100 000 /mL at screening
9. Haemoglobin < 9.0 g/dL at screening
10. In the opinion of the Investigator, patient is likely to have lung transplantation during study (but being on transplantation list is acceptable for participation).
11. Life expectancy for disease other than IPF < 2.5 years (Investigator assessment).
12. Other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial.
• Myocardial infarction during the previous 6 months
• Unstable angina during the previous month
13. Other investigational therapy received within 8 weeks prior to screening visit.
14. Pregant women or 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 enrolment (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.
15. Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential).
16. Known or suspected active alcohol or drug abuse.
17. Bleeding risk
• Known inherited predisposition to bleeding.
• 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.
• History of hemorrhagic CNS event within 12 months prior to screening (visit 1).
• Any of the following within 3 months prior to screening :
o Gross / frank haemoptysis or haematuria
o Active gastro-intestinal bleeding or ulcers
o Major injury or surgery.
18. Thrombotic risk
• Known inherited predisposition to thrombosis.
• History of thrombotic event (including stroke and transient ischemic attacks) within 12 months prior to screening
19. Surgical procedures planned to occur during trial period.
20. Coagulopathy.
21. Uncontrolled systemic arterial hypertension.
22. Known hypersensitivity to lactose or any other component of the study medication.


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

Health Condition(s) or Problem(s) studied

Idiopathic pulmonary fibrosis
MedDRA version: 9.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis

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-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective:

Main Objective: To investigate the efficacy and safety of four doses strategies of BIBF 1120 treatment for 12 months compared to placebo in patients with Idiopathic Pulmonary Fibrosis

Primary end point(s): The primary endpoint is the rate of decline in FVC (expressed in mL per year), evaluated from baseline until 12 month of treatment, compared to placebo

Secondary ID(s)

1199.30