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    Summary
    EudraCT Number:2015-000995-88
    Sponsor's Protocol Code Number:V00305SB301
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-04
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-000995-88
    A.3Full title of the trial
    Study of efficacy and safety of V0305 solution in children suffering from Iron Deficiency Anaemia (IDA).
    Phase 3, multicentre, single arm open-label study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of V0305 solution in children suffering from Iron Deficiency Anaemia (IDA).
    A.4.1Sponsor's protocol code numberV00305SB301
    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 SponsorPierre Fabre Médicament
    B.1.3.4CountryFrance
    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 supportInstitut de Recherche Pierre Fabre
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherche Pierre Fabre
    B.5.2Functional name of contact pointClinical Study Manager A.Stennevin
    B.5.3 Address:
    B.5.3.1Street AddressBP 13562 -3 avenue Hubert Curien
    B.5.3.2Town/ cityTOULOUSE Cedex 01
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number+335 34 50 60 83
    B.5.5Fax number+335 34 50 65 92
    B.5.6E-mailaline.stennevin@pierre-fabre.com
    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.3.2Product code V0305
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 7782-63-0
    D.3.9.2Current sponsor codeV0305
    D.3.9.3Other descriptive nameFERROUS SULFATE HEPTAHYDRATE
    D.3.9.4EV Substance CodeSUB21826
    D.3.10 Strength
    D.3.10.1Concentration unit millilitre(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 Yes
    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
    Iron Deficiency Anaemia
    E.1.1.1Medical condition in easily understood language
    Aneamia
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To document the effect of V0305 administered during 3 months (princeps period) on the blood haemoglobin level in children with IDA .
    E.2.2Secondary objectives of the trial
    - To document the effect of V0305 administered during 6 months (the princeps 3-month period then a second period of 3 additional months) on the blood haemoglobin level in children with IDA .
    - To document the effect of V0305 administered during 3 months then 3 additional months on the serum ferritin level (restoration of iron stores) in children with IDA
    - To assess the acceptability of the formulation by the parent(s)/guardian(s) and the global satisfaction regarding the treatment and the ease of adaptation of the dose by the investigator at the end of the study.
    - To document the tolerance of V0305 administered during 3 to 6 months in children with IDA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female and male child,
    - Child aged between 6 months to 53 months (inclusive),
    - 7.0 kg < (or =) Body Weight < (or =) 20.0 kg,
    - Child presenting a mild or moderate IDA defined by:
    o blood haemoglobin level between 70 and 109 g/L (ref WHO)
    o serum ferritin concentration < 12 µg/L (ref WHO)
    - Child whose parent(s) or guardian(s) have given his/her (their) written informed consent for the child participation in the study, according to national regulations.
    E.4Principal exclusion criteria
    Related to pathologies:
    - Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
    - Haemochromatosis or iron overload of secondary origin (blood transfusion),
    - Presence of gastro duodenal ulcer,
    - Inflammatory bowel disease or any digestive disease which could modify iron absorption,
    - Child presenting any clinically significant condition (abnormality on physical examination or laboratory test results) which, in the opinion of the investigator, could interfere with the interpretation of study data, or which otherwise contraindicates participation in the study,
    - Child suffering from Pica syndrome.

    Related to treatments:
    - Oral or parenteral iron treatment within 3 weeks prior to V1
    - Child with a history of hypersensitivity to at least one of the components of the tested products, including fructose intolerance (due to sorbitol excipient),
    - Child with a history of intolerance to oral iron derivatives,
    - Child needing a long term treatment known to modify iron absorption.

    Others:
    - Child being a family member or a child of a work associate (secretary, nurse, technician) of the investigator,
    - Child participation in another clinical trial,
    - Child in exclusion period in another clinical trial, having received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial,
    - Parent(s) or guardian(s) linguistically or psychologically not able to understand the protocol or to comply with its requirements or to attend to visits,
    - Child and parent(s) or guardian(s) unlikely to be compliant during the study according to the judgment of the Investigator,
    - Parent(s)/guardian(s) not able to be reached by phone.
    E.5 End points
    E.5.1Primary end point(s)
    Blood haemoglobin level at Month 3 (V4, Day 90 ± 7 days)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3 (V4, Day 90 ± 7 days)
    E.5.2Secondary end point(s)
    For all subjects:
    - Haemoglobin responder criterion at Month 3 (V4, Day 90 ± 7 days) defined by a normalisation of blood haemoglobin level (blood haemoglobin level > or = to 110 g/L),
    - Serum ferritin level at Week 3 (V3, Day 21 ± 2 days), Month 3 (V4, Day 90 ± 7 days),
    - Ferritin responder criterion at Month 3(V4, Day 90 ± 7 days) defined by a normalisation of serum ferritin level (serum ferritin level > or = to 12 µg/L);
    - Combined responder criterion, defined by a normalisation of both blood haemoglobin and serum ferritin levels at Month 3 (V4, Day 90 ± 7 days),
    - Haemoglobin level and reticulocytes count at Week 3 (V3, Day 21 ± 2 days),
    - Acceptability of this formulation assessed by the parent(s)/guardian(s) (questionnaire) at Week 3 (V3, Day 21 ± 2 days), Month 3 (V4, Day 90 ± 7 days),
    - Evaluation by the investigator of the global satisfaction regarding the treatment at Week 3 (V3, Day 21 ± 2 days), Month 3 (V4, Day 90 ± 7 days),
    - Evaluation by the investigator of the ease of adaptation of the dose (questionnaire) at Week 3 (V3, Day 21 ± 2 days), Month 3 (V4, Day 90 ± 7 days).

    For subjects without a normalisation of both blood haemoglobin and serum ferritin levels at Month 3(V4), who are treated up to Month 6 :
    - Blood haemoglobin level and serum ferritin level at Month 6 (V5, Day 180 ± 7 days),
    - Haemoglobin responder criterion at Month 6 (V5, Day 180 ± 7 days) defined by a normalisation of blood haemoglobin level,
    - Ferritin responder criterion at Month 6 (V5, Day 180 ± 7 days) defined by a normalisation of serum ferritin level,
    - Combined responder criterion, defined by a normalisation of blood haemoglobin and serum ferritin levels at Month 6 (V5, Day 180 ± 7 days),
    - Acceptability of this formulation (questionnaire) assessed by the parent(s)/guardian(s) at Month 6 (V5, Day 180 ± 7 days) or in case of premature withdrawal,
    - Evaluation by the investigator of the global satisfaction regarding the treatment and the ease of adaptation of the dose (questionnaire) at Month 6 (V5, Day 180 ± 7 days) or in case of premature withdrawal,

    Safety measures:
    - Tolerance by recording the adverse events, physical examination, laboratory data and vital signs during all the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For all subjects:
    - Month 3 (V4, Day 90 ± 7 days),
    - Week 3 (V3, Day 21 +/- 2 days).

    For subjects without a normalisation of both blood haemoglobin and serum ferritin levels at Month 3(V4), who are treated up to Month 6 :
    Month 6 (V5, Day 180 ± 7 ).
    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 No
    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 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 No
    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 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 concerned5
    E.8.5The trial involves multiple Member States No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 250
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 125
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 125
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    children (6 months to 53 months inclusive)
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    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 Decision2016-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-30
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