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    Summary
    EudraCT Number:2018-003619-23
    Sponsor's Protocol Code Number:6630-4200-42
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-003619-23
    A.3Full title of the trial
    EFFICACY AND SAFETY OF A PARENTERALLY ADMINISTERED FIXED VITAMIN COMBINATION (VITAMIN B6, B12 AND FOLIC ACID) ON VITAMIN B12 STATUS AND METHYLATION CAPACITY IN COBALAMIN DEFICIENCY COMPARED TO ORAL VITAMIN B12 SUPPLEMENTATION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the efficacy and tolerability of a vitamin administration as a syringe with an intake as a tablet
    A.3.2Name or abbreviated title of the trial where available
    EASYVit
    A.4.1Sponsor's protocol code number6630-4200-42
    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 SponsorMEDICE Arzneimittel Pütter GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportMEDICE Arzneimittel Pütter GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBundesinstitut für Arzneimittel und Medizinprodukte
    B.5.2Functional name of contact pointFachgebiet Klinische Prüfung
    B.5.3 Address:
    B.5.3.1Street AddressKurt-Georg-Kiesinger-Allee 3
    B.5.3.2Town/ cityBonn
    B.5.3.3Post code53175
    B.5.3.4CountryGermany
    B.5.4Telephone number+492282074318
    B.5.5Fax number+492282074355
    B.5.6E-mailklinpruefung@bfarm.de
    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 Yes
    D.2.1.1.1Trade name Medivitan® iV Fertigspritze 5 mg, 1 mg 1,05 mg, Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderMEDICE Arzneimittel Pütter GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMedivitan iV
    D.3.4Pharmaceutical form Solution for injection/infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular and intravenous use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCyanocobalamin
    D.3.9.3Other descriptive nameCYANOCOBALAMIN
    D.3.9.4EV Substance CodeSUB06837MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPyridoxinhydrochlorid
    D.3.9.1CAS number 58-56-0
    D.3.9.4EV Substance CodeSUB15062MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFolic Acid
    D.3.9.3Other descriptive nameFOLIC ACID
    D.3.9.4EV Substance CodeSUB07774MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.21
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name B12 Ankermann
    D.2.1.1.2Name of the Marketing Authorisation holderWörwag Pharma GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameB12 Ankermann
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNCyanocobalamin
    D.3.9.3Other descriptive nameCYANOCOBALAMIN
    D.3.9.4EV Substance CodeSUB06837MIG
    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) 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
    vitamin B12 deficiency
    E.1.1.1Medical condition in easily understood language
    vitamin B12 deficiency
    E.1.1.2Therapeutic area Not possible to specify
    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 investigate the effects of a parenterally vitamin B12 combination treatment versus an oral vitamin B12 mono therapy on the vitamin B12 status in female and male patients as determined by the change from baseline in serum vitamin B12 concentration after 4 weeks (28 days) of treatment.
    E.2.2Secondary objectives of the trial
    Serum holotranscobalamin
    Serum homocysteine
    Serum methylmalonic acid
    Combined vitamin B12 markers (cB12)
    Serum folic acid
    Serum vitamin B6
    Serum S-adenosylmethione (SAM)
    Serum S-adenosylhomocysteine (SAH)
    SAM/SAH ratio
    WHO-5 Well-Being Index.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Provision of written informed consent to participate in the study (according to AMG §40 (1)3b).
    Female and male patients aged ≥18.
    Diagnosis of vitamin B12 deficiency, defined as serum vitamin B12 < 350 pmol/L.
    Female patients of childbearing potential (WOCBP) must be using two acceptable methods of contraception
    E.4Principal exclusion criteria
    Active or recent vitamin B12 intake (the subject must not receive vitamin B12 drugs or food supplements for at least 6 months).
    Participation in a previous clinical study with vitamin B12 within the 6 months prior to screening.
    Any contraindication to one of the study drugs.
    Pregnant or nursing (lactating) women.
    Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
    Subjects with anemia (haemoglobin < 10 mg/dL) or neurological symptoms due to vitamin B12 deficiency.
    Any diseases that prevent intrinsic-factor independent passive diffusion in the small intestine (e.g. ileum resection)
    Current drug addiction and/or alcohol abuse as evidenced by patient history and/or as determined by the investigator at V-1.
    Cognitive or behavioral abnormalities that could impair the capacity to give informed consent or carry out protocol-specified procedures.
    Inability to take oral medication
    E.5 End points
    E.5.1Primary end point(s)
    serum vitamin B12 concentration (pmol/L).
    E.5.1.1Timepoint(s) of evaluation of this end point
    change from baseline to week 4 (28 days) in
    E.5.2Secondary end point(s)
    Serum holotranscobalamin
    Serum homocysteine
    Serum methylmalonic acid
    Combined vitamin B12 markers (cB12)
    Serum folic acid
    Serum vitamin B6
    Serum S-adenosylmethione (SAM)
    Serum S-adenosylhomocysteine (SAH)
    SAM/SAH ratio
    WHO-5 Well-Being Index.
    Adverse events (AEs)
    Serious adverse events (SAEs) and suspected unexpected serious adverse drug reactions (SUSARs)
    Vital signs (body weight, blood pressure and pulse rate)
    Clinical laboratory tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    changes from baseline to week 4
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    last visit of the last subject
    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 months6
    E.8.9.1In the Member State concerned days
    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: 30
    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 state40
    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 Decision2019-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
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