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    Summary
    EudraCT Number:2005-005524-13
    Sponsor's Protocol Code Number:I-ICRNS-005-PRCLD-DVT-01
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-01-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2005-005524-13
    A.3Full title of the trial
    Defibrotide in the prevention of recurrences in venous thrombosis: DEPRIVE.
    A randomised, multicentre, European, double blind, parallel group study, to assess the efficacy and tolerability of defibrotide versus placebo in the prevention of recurrences in venous thromboembolism
    A.3.2Name or abbreviated title of the trial where available
    DEPRIVE
    A.4.1Sponsor's protocol code numberI-ICRNS-005-PRCLD-DVT-01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCRINOS S.p.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name PROCICLIDE
    D.2.1.1.2Name of the Marketing Authorisation holderCRINOS
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDefibrotide
    D.3.2Product code Defibrotide
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    DVT and PE are part of the same disease that can be defined Venous Thromboembolism (VTE). Treatment of the acute phases is well established: LMWH during the first days and OAT for 3-12 months. After cessation of OAT, recurrence venous thromboembolism (VTE) often occurs, with an estimated early rate of 6-9%. Defibrotide possesses antithrombotic, anti-ischemic and thrombolytic properties, without anti-coagulant effects. Defibrotide after cessation of OAT could reduce the recurrence rate of VTE
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Level PT
    E.1.2Classification code 10051055
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether oral defibrotide treatment may offer a 50% increase in the protection against the recurrenceof DVT, and further confirm its safety in long term administration.
    E.2.2Secondary objectives of the trial
    To assess the effect of oral defibrotide treatment on other thrombo-embolic events, venous and arterial, and VTE related cardiovascular mortality, objectively assessed, during treatment, in comparison with placebo. To evaluate the changes in in the patient´s assessment of the Quality of Life, and to confirm the long term safety of oral defibrotide treatment. To evaluate the acceptance of treatment both by the patient and by the investigator.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Adult male or female outpatients, age 18-75 years. Have suffered from a documented recent episode of DVT (within 1 year of the screening visit),
    irrespective whether the DVT episode was provoked or non provoked, first episode or recurrence, OAT must be ended since 30 days on the date of the screening visit.
    E.4Principal exclusion criteria
    Patients who still present signs of active DVT at color flow Doppler scanning, Female patients in child bearing age not using adequate contraceptive method, or using oral hormonal contraception, obesity as defined by a Body Mass Index (BMI) 32 kg/m2 (see appendix 28.5), severe alteration of coagulation parameters, clinically relevant kidney function impairment (serum creatinine exceeding 150% of the upper normal range), clinically relevant impairment of liver function (serum enzymes and/or bilirubin exceeding 150% of the upper normal range), subjects who receive concomitant fibrinolytic drugs and/or platelet aggregation inhibitors, ASA, NSAIDS, that cannot be withdrawn without prejudice to the health, subjects that receive veno-active drugs (e.g.: diosmine, rutosides), subjects presentingwith congestive hearth failure (NYHA clas III and IV), (see appendix 28.6). Patients suffering from peripheral obstructive arterial disease.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first episode of recurrence of DVT, objectively confirmed, during treatment, in comparison with placebo group.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Crinos SpA reserves the right to discontinue the study at any time, for internal reasons, for lack of efficacy or safety reasons. Crinos may discontinue a study site, because of significant deviations from the study protocol, or due to insurmountable difficulties experienced in running the study at that center or unacceptable delays in obtaining the ethical or administrative authorisations
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months38
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months38
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 750
    F.4.2.2In the whole clinical trial 810
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Actually there is no consensus on a specific treatment after cessation of OAT. Some family doctors do administer ASA or other platelet aggregation inhibiting drugs after cessation of OAT, although without any scientific evidence.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2006-09-21
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