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Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis
This study is ongoing, but not recruiting participants.
First Received: August 9, 2007   Last Updated: August 20, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00514683
  Purpose

The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis.

The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).

As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy


Condition Intervention Phase
Pulmonary Fibrosis
Drug: BIBF1120
Phase II

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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. [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • FVC changes ; survival ; SpO2 changes ;PaO2 changes ;DLCO changes ; 6MWT ; spirometric parameters ; Patient reported outcomes ; plethysmographic parameters ; exacerbations of IPF ; time to progression ; PK ;Time to O2 supplementation ; CPI ; biomarkers [ Time Frame: 52 weeks ]

Estimated Enrollment: 432
Study Start Date: August 2007
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

    Predicted normal values will be calculated according to ESCS (R94-1408):

    Males :

    FVC predicted (L) = 5.76 x height (meters)- 0.026 x age (years) -4.34

    Females :

    FVC predicted (L) = 4.43 x height (meters)- 0.026 x age (years) -2.89

  6. Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted .

    Different sites may use different prediction formulas, based on the method used to measure DLco. In any case, the method used must be in compliance with the ATS/ERS guideline on DLCO measurements (R06-2002), and the prediction formula appropriate for that method. Raw data (gas mixture, equation used for prediction of normal, further adjustments made if so) must be traced.

    Adjustment for haemoglobin (R06-2002):

    Males :

    DLCO predicted for Hb = DLCO predicted x (1.7Hb/[10.22+Hb])

    Females :

    DLCO predicted for Hb = DLCO predicted x (1.7Hb/[9.38+Hb]) where Hb is expressed in g/dL-1

  7. PaO2 >= 55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air

Exclusion Criteria:

  1. AST, ALT > 1.5 x ULN ;
  2. Bilirubin > 1.5 x ULN
  3. Relevant airways obstruction
  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
  7. International normalised ratio (INR) > 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN

    ;

  8. Platelets < 100 000 /mL
  9. Haemoglobin < 9.0 g/dL
  10. In the opinion of the Investigator, patient is likely to have lung transplantation during study
  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. Pregnant 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.
  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, Patients who require full-dose antiplatelet therapy, History of hemorrhagic CNS event within 12 months prior to screening , Any of the following within 3 months prior to screening : Gross / frank haemoptysis or haematuria, Active gastro-intestinal bleeding or ulcers, Major injury or surgery
  18. Thrombotic risk
  19. Surgical procedures planned to occur during trial period.
  20. Coagulopathy
  21. Uncontrolled systemic arterial hypertension
  22. known hypersensitivity to lactose or any component of the study medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514683

  Show 93 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1199.30
Study First Received: August 9, 2007
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00514683     History of Changes
Health Authority: Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica);   Australia: Responsilble Ethics Committee;   Belgium: Federal Agency for Medicines and Health Products;   Brazil: ANVISA;   Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia;   Canada: Therapeutic Products Directorate;   Chile: Instituto de Salud Publica de Chile;   China: State Food and Drug Administration;   Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE;   Germany: Bundesinstitut für Arzneimittel und Medizinprodukte, Fachregistratur Z 14.02.06, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn;   Great Britain: MHRA;   Greece: National Organization for Medicines (EOF) National Ethics Committee;   Hungary: National Institute of Pharmacy, H-1051 Budapest;   Ireland: Irish Medicines Board;   Italy: Comitato Etico Provinciale di Modena - MODENA;   Korea, Republic of: Korea Food and Drug Administration (KFDA);   Mexico: Federal Commission for Protection Against Health Risks;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Portugal: INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. Parque de Saúde de Lisboa - Avenida do Brasil, 53 1749-004 Lisboa - Portugal;   Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow;   South Africa: Medicines Control Council;   Spain: Spanish Agency for Medicines and Health Products;   Taiwan: Department of Health, Executive Yuan, Taiwan;   Turkey: Ministry of Health Central Ethics Committee

Study placed in the following topic categories:
Lung Diseases, Interstitial
Respiratory Tract Diseases
Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases
Pulmonary Fibrosis

Additional relevant MeSH terms:
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Fibrosis
Lung Diseases
Pulmonary Fibrosis

ClinicalTrials.gov processed this record on September 04, 2009