Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients

NCT ID: NCT01335464

Last Updated: 2016-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-10-31

Brief Summary

Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

Conditions

Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIBF 1120

patient receives capsules containing BIBF 1120 twice a day

Group Type: EXPERIMENTAL

BIBF 1120

Intervention Type: DRUG

BIBF1120 BID (twice daily)

placebo

patient receives capsules identical to those containing active drug

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo matching BIBF1120, BID

Interventions

placebo

placebo matching BIBF1120, BID

Intervention Type: DRUG

BIBF 1120

BIBF1120 BID (twice daily)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age >= 40 years;

2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years;

3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF

4. Dlco (corrected for Hb): 30%-79% predicted of normal;

5. FVC>= 50% predicted of normal

Exclusion Criteria

1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)

2. Bilirubin > 1.5 x ULN;

3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);

4. Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);

5. Myocardial infarction within 6 months;

6. Unstable angina within 1 month;

7. 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);

8. Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;

9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN);

10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1;

11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1199.32.10007 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

1199.32.10029 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

1199.32.10013 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

1199.32.10005 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1199.32.10022 Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

1199.32.10025 Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

1199.32.10023 Boehringer Ingelheim Investigational Site

Weston, Florida, United States

1199.32.10001 Boehringer Ingelheim Investigational Site

Council Bluffs, Iowa, United States

1199.32.10028 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

1199.32.10016 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

1199.32.10024 Boehringer Ingelheim Investigational Site

New Brunswich, New Jersey, United States

1199.32.10019 Boehringer Ingelheim Investigational Site

New York, New York, United States

1199.32.10004 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

1199.32.10020 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

1199.32.10002 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

1199.32.10033 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

1199.32.10008 Boehringer Ingelheim Investigational Site

Providence, Rhode Island, United States

1199.32.10015 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

1199.32.10034 Boehringer Ingelheim Investigational Site

Shelbyville, Tennessee, United States

1199.32.10009 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

1199.32.10018 Boehringer Ingelheim Investigational Site

McKinney, Texas, United States

1199.32.10021 Boehringer Ingelheim Investigational Site

Falls Church, Virginia, United States

1199.32.10003 Boehringer Ingelheim Investigational Site

Lynchburg, Virginia, United States

1199.32.10038 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

1199.32.61001 Boehringer Ingelheim Investigational Site

Camperdown, New South Wales, Australia

1199.32.61002 Boehringer Ingelheim Investigational Site

Concord, New South Wales, Australia

1199.32.61003 Boehringer Ingelheim Investigational Site

Daw Park, South Australia, Australia

1199.32.61005 Boehringer Ingelheim Investigational Site

Frankston, Victoria, Australia

1199.32.61004 Boehringer Ingelheim Investigational Site

Prahran, Victoria, Australia

1199.32.32004 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1199.32.32005 Boehringer Ingelheim Investigational Site

Jette, , Belgium

1199.32.32001 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

1199.32.32002 Boehringer Ingelheim Investigational Site

Yvoir, , Belgium

1199.32.86001 Boehringer Ingelheim Investigational Site

Beijing, , China

1199.32.86002 Boehringer Ingelheim Investigational Site

Beijing, , China

1199.32.86005 Boehringer Ingelheim Investigational Site

Changsha, , China

1199.32.86004 Boehringer Ingelheim Investigational Site

Chengdu, , China

1199.32.86003 Boehringer Ingelheim Investigational Site

Nanchang, , China

1199.32.86006 Boehringer Ingelheim Investigational Site

Xi'an, , China

1199.32.42002 Boehringer Ingelheim Investigational Site

Prague, , Czechia

1199.32.42003 Boehringer Ingelheim Investigational Site

Prague, , Czechia

1199.32.42001 Boehringer Ingelheim Investigational Site

Ústí nad Labem, , Czechia

1199.32.33002 Boehringer Ingelheim Investigational Site

Bobigny, , France

1199.32.33003 Boehringer Ingelheim Investigational Site

Nice, , France

1199.32.33001 Boehringer Ingelheim Investigational Site

Paris, , France

1199.32.33005 Boehringer Ingelheim Investigational Site

Paris, , France

1199.32.33006 Boehringer Ingelheim Investigational Site

Paris, , France

1199.32.33007 Boehringer Ingelheim Investigational Site

Reims, , France

1199.32.33004 Boehringer Ingelheim Investigational Site

Rennes, , France

1199.32.49008 Boehringer Ingelheim Investigational Site

Bamberg, , Germany

1199.32.49005 Boehringer Ingelheim Investigational Site

Donaustauf, , Germany

1199.32.49001 Boehringer Ingelheim Investigational Site

Essen, , Germany

1199.32.49002 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, , Germany

1199.32.49006 Boehringer Ingelheim Investigational Site

Giessen, , Germany

1199.32.49003 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

1199.32.49007 Boehringer Ingelheim Investigational Site

Heidelberg, , Germany

1199.32.49004 Boehringer Ingelheim Investigational Site

Mainz, , Germany

1199.32.91003 Boehringer Ingelheim Investigational Site

Ahmedabad, , India

1199.32.91002 Boehringer Ingelheim Investigational Site

Coimbatore, , India

1199.32.91006 Boehringer Ingelheim Investigational Site

Jaipur, , India

1199.32.91005 Boehringer Ingelheim Investigational Site

Kolkata, , India

1199.32.91001 Boehringer Ingelheim Investigational Site

Mumbai, , India

1199.32.35301 Boehringer Ingelheim Investigational Site

Dublin, , Ireland

1199.32.97004 Boehringer Ingelheim Investigational Site

Haifa, , Israel

1199.32.97001 Boehringer Ingelheim Investigational Site

Petah Tikva, , Israel

1199.32.97002 Boehringer Ingelheim Investigational Site

Rehovot, , Israel

1199.32.39012 Boehringer Ingelheim Investigational Site

Catania, , Italy

1199.32.39004 Boehringer Ingelheim Investigational Site

Chieti Scalo, , Italy

1199.32.39008 Boehringer Ingelheim Investigational Site

Forlì, , Italy

1199.32.39005 Boehringer Ingelheim Investigational Site

Milan, , Italy

1199.32.39001 Boehringer Ingelheim Investigational Site

Modena, , Italy

1199.32.39007 Boehringer Ingelheim Investigational Site

Monza, , Italy

1199.32.39011 Boehringer Ingelheim Investigational Site

Napoli, , Italy

1199.32.39002 Boehringer Ingelheim Investigational Site

Padua, , Italy

1199.32.39006A Boehringer Ingelheim Investigational Site

Pisa, , Italy

1199.32.39006B Boehringer Ingelheim Investigational Site

Pisa, , Italy

1199.32.39010 Boehringer Ingelheim Investigational Site

Roma, , Italy

1199.32.39009 Boehringer Ingelheim Investigational Site

Siena, , Italy

1199.32.81005 Boehringer Ingelheim Investigational Site

Bunkyo-ku,Tokyo, , Japan

1199.32.81006 Boehringer Ingelheim Investigational Site

Bunkyo-ku,Tokyo, , Japan

1199.32.81007 Boehringer Ingelheim Investigational Site

Kiyose, Tokyo, , Japan

1199.32.81004 Boehringer Ingelheim Investigational Site

Kumagaya, Saitama, , Japan

1199.32.81009 Boehringer Ingelheim Investigational Site

Minato-ku, Tokyo, , Japan

1199.32.81003 Boehringer Ingelheim Investigational Site

Naka-gun, Ibaraki, , Japan

1199.32.81011 Boehringer Ingelheim Investigational Site

Ota-ku, Tokyo, , Japan

1199.32.81001 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, , Japan

1199.32.81010 Boehringer Ingelheim Investigational Site

Shibuya-ku, Tokyo, , Japan

1199.32.81002 Boehringer Ingelheim Investigational Site

Shimotsuke,Tochigi, , Japan

1199.32.81008 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

1199.32.81012 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

1199.32.44006 Boehringer Ingelheim Investigational Site

Aberdeen, , United Kingdom

1199.32.44003 Boehringer Ingelheim Investigational Site

Birmingham, , United Kingdom

1199.32.44005 Boehringer Ingelheim Investigational Site

Birmingham, , United Kingdom

1199.32.44009 Boehringer Ingelheim Investigational Site

Leeds, , United Kingdom

1199.32.44004 Boehringer Ingelheim Investigational Site

Liverpool, , United Kingdom

1199.32.44002 Boehringer Ingelheim Investigational Site

London, , United Kingdom

1199.32.44008 Boehringer Ingelheim Investigational Site

Oxford, , United Kingdom

1199.32.44001 Boehringer Ingelheim Investigational Site

Westbury on Trym, , United Kingdom

Countries

United States; Australia; Belgium; China; Czechia; France; Germany; India; Ireland; Israel; Italy; Japan; United Kingdom

References

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Other Identifiers

2010-024251-87

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.32

Identifier Type: -

Identifier Source: org_study_id