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    Summary
    EudraCT Number:2019-004683-22
    Sponsor's Protocol Code Number:RGCH005
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-29
    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 ConcernedNorway - NOMA
    A.2EudraCT number2019-004683-22
    A.3Full title of the trial
    Daratumumab as a treatment for adult immune thrombocytopenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Daratumumab as a treatment for adult immune thrombocytopenia
    A.3.2Name or abbreviated title of the trial where available
    The DART-study
    A.4.1Sponsor's protocol code numberRGCH005
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOstfold Hospital Trust
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOstfold Hospital Trust
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportRegional Health Authority South East
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOstfold Hospital Trust
    B.5.2Functional name of contact pointSykehuset Østfold
    B.5.3 Address:
    B.5.3.1Street AddressKalnesveien 300
    B.5.3.2Town/ cityGrålum
    B.5.3.3Post code1714
    B.5.3.4CountryNorway
    B.5.4Telephone number+4769860000
    B.5.6E-mailpostmottak@so-hf.no
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedaratumumab
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJnJ 54767414
    D.3.9.3Other descriptive nameHUMAX-CD38
    D.3.9.4EV Substance CodeSUB175772
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immune thrombocytopenia
    E.1.1.1Medical condition in easily understood language
    An autoimmune disease characterized by low platelet count and increased risk of bleeding.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10021245
    E.1.2Term Idiopathic thrombocytopenic purpura
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1- to determine the efficacy of treatment with daratumumab in ITP
    2- to characterize the safety of daratumumab in ITP
    3- to identify the optimal total dose of daratumumab (duration of treatment) to use in future studies
    E.2.2Secondary objectives of the trial
    1. to explore anti-platelet antibody positivity in serum before and after treatment with daratumumab
    2. to explore the immunophenotypic changes in peripheral blood and bone marrow mononuclear cells, before and after exposure to daratumumab
    3. to determine HRQoL and level of fatigue before and after treatment daratumumab and to compare HRQoL in responders vs non-responders.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged ≥18 years.
    2. Primary ITP with a platelet count of ≤30 X 109/L measured within 4 weeks prior to inclusion with failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab or TPO-RA.
    3. Signed and dated written informed consent.
    4. Females of child-bearing potential accepting to follow effective contraceptive methods for at least 3 months following the last administration of daratumumab
    E.4Principal exclusion criteria
    1. Patients with active bleeding
    2. Pregnancy or lactation
    3. Surgery planned within the 3 next months
    4. Secondary ITP: ITP associated with lymphoma, chronic lymphocytic leukemia, drug induced or ITP secondary to autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, common variable immune deficiency, human immunodeficiency virus, or hepatitis C
    5. Concomitant autoimmune hemolytic anemia
    6. Known allergy and/or sensitivity or contraindication to daratumumab
    7. Patients in a severely immune compromised state
    8. Active malignancy
    9. Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
    10. Patient unable to attend all the visits planned for the trial
    11. Known previous infection or seropositivity for Hepatitis B.
    E.5 End points
    E.5.1Primary end point(s)
    The main efficacy end point will be measured by the proportion of patients in each cohort who achieve platelet count >50 X 109/L in 2 measurements within week 12 in cohort 1 and within week 16 in cohort 2, after first daratumumab injection, without having received rescue therapy or having had dose increment of (TPO-RA or corticosteroids) during the last 4 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 or 16 weeks
    E.5.2Secondary end point(s)
    a. The duration of response defined as the cumulative number of weeks with platelet count >50 X 109/L between end of treatment and end of the study or week 24 for last patient, without having received rescue therapy or having had dose increment of corticosteroids in the 4 weeks prior to the first platelet counts >50 X 109/L
    b. Time of first platelet count >50 X 109/L after first daratumumab administration
    c. Proportion of patients in each cohort who achieve platelet count >100 X 109/L during week 12 in cohort 1 and week 16 in cohort 2, after first daratumumab injection without having received any rescue therapy or having had dose increment of (TPO-RA or corticosteroids) during the last 4 weeks prior to week 12 or 16 in the two respective cohorts.
    d. Bleeding episodes during observation time
    e. Time to treatment failure in each cohort, where treatment failure is defined as first platelet count <30 X 109/L, administration of any platelet elevating therapy after achieving response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks or end of study
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    First 10 patients receive 1800mg once a week x 8 and 10 patients receive 1800 mg x 10 times
    E.8.2.4Number of treatment arms in the trial2
    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 EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4
    F.4.2.2In the whole clinical trial 20
    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)
    None
    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 Decision2020-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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