Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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3 February 2014 |
Main ID: |
EUCTR2010-024251-87-DE |
Date of registration:
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09/02/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients
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Scientific title:
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A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) |
Date of first enrolment:
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12/04/2011 |
Target sample size:
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485 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024251-87 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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China
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Czech Republic
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France
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Germany
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India
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Ireland
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Israel
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Italy
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Japan
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United Kingdom
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United States
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Contacts
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Name:
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clintriage.rdg@boehringer-ingelheim
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Address:
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Binger Straße 173
55218
Ingelheim
Germany |
Telephone:
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001800243 0127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim Pharma GmbH & Co. KG |
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Name:
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clintriage.rdg@boehringer-ingelheim
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Address:
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Binger Straße 173
55218
Ingelheim
Germany |
Telephone:
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001800243 0127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim Pharma GmbH & Co. KG |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age = 40 years;
IPF diagnosed, according to most recent ATS/ERS/JRS/ALAT IPF guideline
for diagnosis and management, within 5 years;
Combination of HRCT pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF;
Dlco (corrected for Hb): 30%-79% predicted of normal;
FVC = 50% predicted of normal 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 235
Exclusion criteria: Laboratory parameters (AST, ALT > 1.5 x ULN; Bilirubin > 1.5 x ULN);
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);
Myocardial infarction within 6 months;
Unstable angina within 1 month;
Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months; International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time
(PTT) by > 50% of institutional ULN);
N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1;
Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8
weeks of visit 1;
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Idiopathic Pulmonary Fibrosis MedDRA version: 14.1
Level: PT
Classification code 10021240
Term: Idiopathic pulmonary fibrosis
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Intervention(s)
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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- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use
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- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Annual rate of decline in FVC (expressed in mL over 52 weeks).
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Main Objective: To demonstrate a reduction of lung function decline, as measured by a change of the yearly rate of decline of forced vital capacity (FVC).
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Secondary Objective: To assess the patient's perception of his/her disease, and the time to IPF exacerbation. To investigate respiratory and overall survival, as well as causes of mortality. To assess safety and tolerability.
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Timepoint(s) of evaluation of this end point: The data for the primary endpoint (FVC) are collected over the whole study period and are evaluated at the end of the trial.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: The data for the secondary endpoints are collected over the whole study period and are evaluated at the end of the trial.
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Secondary end point(s): Patient reported outcomes (SGRQ, SGRQ-I, SOBQ, CASA-Q(CD), EQ-5D, PGI-C);
Time to first IPF exacerbation;
Further analyses regarding acute exacerbations; Further analyses on lung function (e.g. FVC, Dlco, SPO2); Survival (on-treatment, overall); respiratory mortality;
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Source(s) of Monetary Support
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Boehringer Ingelheim Pharma GmbH & Co. KG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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