E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic Pulmonary Fibrosis |
Idiopathiás tüdőfibrózis |
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E.1.1.1 | Medical condition in easily understood language |
Idiopathic Pulmonary Fibrosis |
Idiopathiás tüdőfibrózis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021240 |
E.1.2 | Term | Idiopathic pulmonary fibrosis |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to establish the long term tolerability and safety profile of BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis in a roll-over study |
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E.2.2 | Secondary objectives of the trial |
effects of long trem treatment with BIBF 1120 on survival |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is Forced Vital Capacity decline (slope of decline between study entry and end of treatment) |
az FVC csökkenése |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
slope of decline between study entry and end of treatment |
Funkció romlás mértéke a vizsgálatba való belépés és a vizsgálat befejezése között |
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E.5.2 | Secondary end point(s) |
Overall survival Progression Free Survival DLCO decrease IPF acute exacerbations |
Teljes túlélés, progressziómentes túlélés, a DLCO éves csökkenése, IPF exacerbáció |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
DLCO decrease - yearly, IPF acute exacerbations: - Frequency - Time to first occurrence |
a DLCO éves csökkenése, IPF exacerbáció: - Frekvencia - Az első előfordulásig eltelt idő
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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This is a roll-over study planned to be running until necessary i.e. until last patient will have been withdrawn from the trial or a criterion for stopping the trial is met. Criteria for stopping the trial could be :new clinical or non clinical data suggets that the study drug may have a negative benefit/risk ratio ; or the drug becomes available (e.g. on the market or available for a compassionate use) and can be prescribed. |
A vizsgálatba bevont betegek addig vehetnek részt, amíg a beteg kivonása bármely okból szükségessé nem válik, vagy amíg a gyógyszer elérhető lesz. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |