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    Summary
    EudraCT Number:2013-003573-10
    Sponsor's Protocol Code Number:2012GA03
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-003573-10
    A.3Full title of the trial
    Can Vitamin D supplementation improve Hepatitis C cure rates: A pilot multicentre randomised controlled clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can Vitamin D supplementation improve Hepatitis C cure raTes: A pilot multicentre randomised controlled clinical trial. The ViaDUCT Study
    A.3.2Name or abbreviated title of the trial where available
    The ViaDUCT study
    A.4.1Sponsor's protocol code number2012GA03
    A.5.4Other Identifiers
    Name:Sponsor R&D numberNumber:2012GA03
    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 SponsorUniversity of Dundee & NHS Tayside
    B.1.3.4CountryUnited Kingdom
    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 supportChief Scientist Office, Scottish Government
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Dundee, Tayside Clinical Trials Unit
    B.5.2Functional name of contact pointStephen McSwiggan
    B.5.3 Address:
    B.5.3.1Street AddressTASC, Level 3 Ninewells Hospital
    B.5.3.2Town/ cityDundee
    B.5.3.3Post codeDD1 9SY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01382383233
    B.5.6E-mails.j.mcswiggan@dundee.ac.uk
    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 Vigantol Oil
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KgAA
    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 nameCholecalciferol
    D.3.4Pharmaceutical form Oral liquid
    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 INN(5Z,7E)-9,10-Secocholesta-5,7,10(19)-trien-3β-ol
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor codeColecalciferol
    D.3.9.3Other descriptive nameCholecalciferol
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral liquid
    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
    Hepatitis C virus
    E.1.1.1Medical condition in easily understood language
    Hepatitis C
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10065051
    E.1.2Term Acute hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to test if vitamin D supplementation improves the chances of standard treatment for HCV infection being effective. To test this we will measure if there is an improvement in the virologic response - ie the level of virus in the blood, 12 weeks after completion of treatment.
    E.2.2Secondary objectives of the trial
    • To determine the proportion of patients with rapid virological response (RVR is defined as negative viral load after only 4 weeks of therapy)
    • To determine the proportion of eligible patients undergoing standard therapy for HCV infection who consent to the study and the drop out rate from therapy of those who consent as compared to those who do not consent in order to establish if a larger multi centre trial to follow this one is feasible.
    • To determine the proportion of patients with sustained virologic response (SVR) at 24 weeks. (A SVR is defined as undetectable viral load 24 weeks after cessation of therapy).
    • To determine the impact on the immune system of supplementation with Vitamin D3 as measured by immune markers in the blood.
    • To determine the effect of supplementation with Vitamin D on adherence to standard HCV therapy.
    • To establish the cost effectiveness of the Vitamin D intervention modelled on treating all and treating those deficient on testing.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Have confirmed hepatitis C with positive PCR for genotype 1 or 3
    • Are planned to commence on standard eradication therapy for HCV
    • Aged 18 or over
    E.4Principal exclusion criteria
    • Hepatitis C genotype other than 1 or 3
    • Previous treatment with interferon/ribivarin
    • Contraindications to interferon / ribavirin therapy
    • eGFR <30 ml/min (by MDRD4 method)
    • Currently decompensated liver disease
    o Ascites, encephalopathy or variceal bleeding
    • History of renal calculi
    • Serum calcium <2.15 mmol/L or >2.60 mmol/L
    • History of sarcoidosis, metastatic malignancy
    • Hepatocellular carcinoma (current or previous)
    • Taking >400 units/day of vitamin D
    • HIV positive
    • Pregnancy
    • Breastfeeding
    • Of childbearing potential and not taking reliable contraception
    • Participation in another drug trial concurrently or within 30 days of screening for this one
    • Unable to provide written informed consent
    E.5 End points
    E.5.1Primary end point(s)
    To determine the proportion of patients with sustained virologic response (SVR) at 12 weeks post standard therapy on Vitamin D3 as compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 month visit
    E.5.2Secondary end point(s)
    1) To determine the proportion of patients with rapid virological response (RVR is defined as negative HCV PCR at 4 weeks of therapy) and who therefore receive response guided shortened therapy.
    2) To determine the proportion of eligible patients undergoing standard therapy for HCV infection who consent to the study and the drop out rate from therapy of those who consent as compared to those who do not consent.
    3) To determine the proportion of patients with sustained virologic response (SVR) at 24 weeks. (A SVR is defined as undetectable HCV RNA 24 weeks after cessation of therapy. If this is not available a surrogate of undetectable HCV RNA at greater than 12 weeks after cessation of therapy will be used).
    4). To determine the impact on the immune system of supplementation with Vitamin D3 as measured by immune markers.
    5)To determine the effect of supplementation with Vitamin D3 on adherence to standard HCV therapy.
    6) To establish the cost effectiveness of the Vitamin D intervention modelled on treating all and treating those deficient on testing.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)- 1 month
    2)- 2.5 year (at study end post LPLV)
    3)-12 month
    4)-12 month
    5)-12 month
    6) - 1.5 year (at study end post LPLV)
    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 No
    E.6.5Efficacy No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 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
    Last visit of the last participant
    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 months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    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 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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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)
    Participants will be informed of treatment allocation at the end of the study when results are analysed. No arrangements have been made for prescribing of the study medication post study. The dose given is not available over the counter or on prescription.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-22
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