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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2010-022247-37
    Sponsor's Protocol Code Number:BDP-GVHD-03
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-10-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-022247-37
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY OF THE SAFETY AND EFFICACY OF ORBEC® (ORAL BECLOMETHASONE 17,21-DIPROPIONATE) IN CONJUNCTION WITH TEN DAYS OF HIGH-DOSE PREDNISONE THERAPY IN THE TREATMENT OF PATIENTS WITH GASTROINTESTINAL GRAFT VS. HOST DISEASE
    A.4.1Sponsor's protocol code numberBDP-GVHD-03
    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 SponsorSoligenix, Inc.
    B.1.3.4CountryUnited States
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/02/093
    D.3 Description of the IMP
    D.3.1Product nameoral beclomethasone 17,21-dipropionate
    D.3.2Product code BDP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBeclometasone dipropionate
    D.3.9.1CAS number 5534-09-8
    D.3.9.2Current sponsor code2106DM0 for micronized product
    D.3.9.3Other descriptive namebeclometasone dipropionate (D.C.I.); beclomethasone dipropionate (USAN, BAN)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.8Extractive medicinal product No
    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.IMP: 2
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/02/093
    D.3 Description of the IMP
    D.3.1Product nameoral beclomethasone 17,21-dipropionate
    D.3.2Product code BDP
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBeclometasone dipropionate
    D.3.9.1CAS number 5534-09-8
    D.3.9.2Current sponsor code2106DM0 for micronized product
    D.3.9.3Other descriptive namebeclometasone dipropionate (D.C.I.); beclomethasone dipropionate (USAN, BAN)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.8Extractive medicinal product No
    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 placeboTablet
    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
    Patients with acute gastrointestinal Graft Versus Host Disease.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10064677
    E.1.2Term Graft versus host disease in intestine
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this confirmatory, multi-center study is to compare the efficacy, defined as the proportion of subjects who are GVHD treatment successes vs. failures, of an oral BDP regimen consisting of an induction course of prednisone [1 mg/kg/day for ten (10) days] plus 8 mg/day BDP for fifty (50) days, with the efficacy of an induction course of prednisone [1 mg/kg/day for ten (10) days] plus placebo tablets for fifty (50) days, in subjects with acute gastrointestinal (GI) GVHD.
    E.2.2Secondary objectives of the trial
    a. Cumulative prednisone exposure (in mg/kg/day) received while under observation during the 80-day study period.
    b. The occurrence of GVHD treatment failure during the 50-day study drug treatment period.
    c. Survival status at Study Day 200 post-randomization.
    d. The presence or absence of active acute GI GVHD at Study Day 110.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    POPULATION PHARMACOKINETICS OF BECLOMETHASONE (BOH), BECLOMETHASONE 17-MONOPROPIONATE (17-BMP) AND BECLOMETHASONE 17,21-DIPROPIONATE DURING ORBEC® (ORAL BECLOMETHASONE 17,21-DIPROPIONATE) TREATMENT OF ACUTE GASTROINTESTINAL GRAFT-VS-HOST DISEASE (GI GVHD) IN PATIENTS UNDERGOING ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION: A PHARMACOKINETIC SUBSTUDY OF THE PHASE 3 STUDY BDP-GVHD-03
    E.3Principal inclusion criteria
    1)Patients must be between 10 and 100 days post-allogeneic hematopoietic cell transplantation.
    2) Symptoms consistent with GI GVHD with endoscopic evidence of GVHD without another plausible explanation for symptoms.
    3) Histologic diagnosis of GVHD within ninety-six (96) hours prior to the first dose of study drug.
    4) Absence of GI infection within seven (7) days prior to the first dose of study drug. (For patients with diarrhea, no stool pathogens can be detected; for patients undergoing endoscopic biopsies, no infectious agents can be found).
    5) Demonstrated ability to swallow two (2) tablets of the size and configuration of study drug.
    6) Anti-candidal prophylaxis with an effective drug prior to the first dose of study drug.
    7) If female and of childbearing potential, must be willing to use adequate contraception, as determined by the investigator, for the duration of the study.
    8) Ability to read, understand, and sign (or have legal representative sign) appropriate patient informed consent.
    9) ≥ (> or =) 18 years of age.
    E.4Principal exclusion criteria
    1) Skin GVHD, other than a slowly evolving rash that involves ≤ (< or =) 50% of the body surface.
    2) Definite liver GVHD by liver histology or clinical criteria or evidence of liver dysfunction with a total serum bilirubin >3 mg/dL plus conjugated (direct) serum bilirubin >1.0 mg/dL.
    3) >1000 mL/day diarrhea on any one (1) day within three (3) days prior to first dose of study drug.
    4) Systemic (oral or IV) corticosteroid use for the purpose of prophylaxis or treatment of GVHD or another inflammatory disease process within thirty (30) days prior to first dose of study drug. Exceptions include: use of corticosteroids as anti-emetics during conditioning therapy, or as a pre-medication for infusion of blood products or, < 2 days of stress coverage. If immediate treatment for presumptive GVHD is clinically indicated, up to two doses of prednisone or equivalent (totaling 1mg/kg/day) may be given while awaiting biopsy results in the 24 hours prior to start of study drug.
    5) Persistent vomiting of oral intake that precludes ingestion of study drug tablets.
    6) Multi-organ failure, sepsis syndrome, or other condition with high mortality (i.e., life expectancy less than 3 months).
    7) Infection of the mouth or esophagus with a fungal organism.
    8) Known HIV seropositivity.
    9) Pregnancy or lactation.
    10)Use of any investigational drug, biologic, or device for treatment of GVHD within previous thirty (30) days.
    11) In the Investigator’s opinion, an inability to comply with the study procedures and scheduled study visits.
    E.5 End points
    E.5.1Primary end point(s)
    The occurrence (yes/no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 Yes
    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
    The trial is consider complete when all enrolled subjets have completed all protocol assessments (through Day 200). The only situation where the last visit of the last subject would NOT be the end of the study would be if the patient died or went to hospice prior to other patients completing Study Day 200 or dying.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 166
    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 Decision2010-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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