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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2017-000694-37
    Sponsor's Protocol Code Number:VHCRP1701
    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:2017-09-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-000694-37
    A.3Full title of the trial
    A phase IIIb, open-label, multicentre, international randomised controlled trial of simplified treatment monitoring for 8 weeks glecaprevir (300mg)/pibrentasvir (120mg) in chronic HCV treatment naïve patients without cirrhosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate how effective and safe a simplified treatment monitoring strategy is when applied to people with chronic hepatitis C virus infection without liver disease and taking glecaprevir/pibrentasvir for 8 weeks
    A.3.2Name or abbreviated title of the trial where available
    SMART-C
    A.4.1Sponsor's protocol code numberVHCRP1701
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03117569
    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 SponsorUniversity of New South Wales Sydney
    B.1.3.4CountryAustralia
    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 supportAbbvie Pty Ltd
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportUniversity of New South Wales Sydney
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of New South Wales Sydney
    B.5.2Functional name of contact pointPhilippa Marks
    B.5.3 Address:
    B.5.3.1Street AddressKirby Institute, University of New South Wales Sydney, Wallace Wurth Building
    B.5.3.2Town/ citySydney, New South Wales
    B.5.3.3Post code2052
    B.5.3.4CountryAustralia
    B.5.4Telephone number0061293850886
    B.5.5Fax number0061293859214
    B.5.6E-mailpmarks@kirby.unsw.edu.au
    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 nameglecaprevir/pibrentasvir
    D.3.2Product code ABT-493/ABT-530
    D.3.4Pharmaceutical form Film-coated 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 INNGlecaprevir
    D.3.9.1CAS number 1365970-03-1
    D.3.9.2Current sponsor codeABT-493
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPibrentasvir
    D.3.9.1CAS number 1353900-92-1
    D.3.9.2Current sponsor codeABT-530
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic hepatitis C virus infection
    E.1.1.1Medical condition in easily understood language
    Chronic hepatitis C infection is infection with hepatitis C virus for more than 6 months
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10008912
    E.1.2Term Chronic 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
    To compare the proportion of participants with undetectable hepatitis C virus load in their blood (HCV RNA less than the lower limit of quantification- LLOQ) at 12 weeks post-treatment (SVR12); following 8 weeks treatment with glecaprevir (300mg)/pibrentasvir (120mg); in people infected with hepatitis C without liver scarring (HCV treatment naïve non-cirrhosis chronic HCV patients), who have received a standard versus simplified schedule of safety and virological monitoring.
    E.2.2Secondary objectives of the trial
    1. To compare the proportion of participants achieving SVR12 between those who received a standard versus simplified schedule of safety and virological monitoring based on modified intention to treat population.

    2. To evaluate the proportion of participants who comply with treatment and study visits (both on-treatment compliance and early treatment discontinuation with be analysed).

    3. To evaluate patient reported outcomes following treatment.

    4. To evaluate safety and tolerability by monitoring adverse events during treatment.

    5. To measure patient satisfaction on both arms.

    6. To evaluate the prevalence and impact of baseline Resistance Associated Substitutions (RAS) on SVR12.

    7. To evaluate cost-effectiveness of simplified monitoring.

    8. To evaluate immunovirological factors associated with treatment clearance.

    9. Exploratory Objective:
    - To measure the provider acceptability of the simplified monitoring strategy.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    At selected sites peripheral blood mononuclear cells (PBMCs) will be collected at the time points specified in the protocol. These will be used for immunovirological research aims. Not all sites will participate in this sub-study as not all sites have the capacity and ability to process and store PBMCs.
    E.3Principal inclusion criteria
    1) Have voluntarily signed the informed consent form.
    2) 18 years of age or older.
    3) Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
    4) HCV RNA plasma ≥ 10,000 IU/ml at screening.
    5) HCV genotype 1-6.
    6) HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).
    7) Stage F0-3, based on: hepatic elastography <12.5 kPa on Fibroscan® or APRI <1.0.
    8) If co-infection with HIV is documented, the subject must meet the following criteria:
    - ART naïve with CD4 T cell count >500 cells/mm3;
    OR
    - On a stable ART regimen for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and a plasma HIV RNA level below the limit of detection.
    9) Negative pregnancy test at screening and baseline (females of childbearing potential only).
    10) All fertile females must be using effective contraception during treatment and during the 30 days after treatment end.
    E.4Principal exclusion criteria
    1) History of any of the following:
    a. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
    b. Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).
    c. Solid organ transplant.
    d. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.

    2) Any of the following lab parameters at screening:
    a. ALT > 10 x ULN
    b. AST > 10 x ULN
    c. Direct bilirubin > ULN
    d. Platelets < 90,000/μL (cells/mm3) if Fibroscan® <12.5 kPa OR < 150,000/μL (cells/mm3) if Fibroscan® is unavailable and patient is included with APRI <1
    e. Creatinine clearance (CLcr) < 50 mL/min
    f. Haemoglobin < 12g/dL for males; <11g/dL for females
    g. Albumin < LLN
    h. INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR

    3) Pregnant or breastfeeding female.

    4) HBV infection (HBsAg positive).

    5) Use of prohibited concomitant medications as described in protocol section 5.3.

    6) Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks).

    7) Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug.

    8) Any investigational drug ≤6 weeks prior to the first dose of study drug.

    9) Ongoing severe psychiatric disease as judged by the treating physician.

    10) Positive result of a urine drug screen at the Screening Visit for opiates, barbiturates, amphetamines, cocaine, benzodiazepines, phencyclidine, propoxyphene, or alcohol, with the exception of a positive result (including methadone) associated with documented short-term use or chronic stable use of a prescribed medication in that class.
    11) Injecting drug use within the previous six months.

    12) Inability or unwillingness to provide informed consent or abide by the requirements of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (week 20) based on ITT population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks post end of treatment (SVR12)
    E.5.2Secondary end point(s)
    1) Proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (week 20) based on mITT population.
    2) Proportion adherent to treatment and study visits (on-treatment adherence and early treatment discontinuation);
    3) Change in health-related quality of life during treatment (measured by EG-5D-3L);
    4) Resistance associated substitutions (RAS): SVR12 in participants with and without baseline RAS, and RAS distribution in participants with virological failures;
    5) Patient treatment satisfaction measured by a questionnaire applied to all participants;
    EXPLORATORY ENDPOINT:
    6) Provider acceptability of simplified monitoring strategy;
    SAFETY ENDPOINTS:
    7) Proportion of patients with common adverse events (reported in greater than 5%).
    8) Proportion of patients with at least one severe or potentially life threatening (grade 3 or 4) adverse event.
    9) Proportion of patients with un-scheduled clinic visits.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) SVR12
    2) SVR12
    3) SVR12
    4) SVR12
    5) SVR12
    6) SVR12
    7) SVR12
    8) SVR12
    9) SVR12
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard treatment monitoring schedule (standard of care)
    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 EEA11
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    France
    Germany
    New Zealand
    Switzerland
    United Kingdom
    United States
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days11
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 375
    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)
    Not applicable, patients will complete treatment whilst on the study and return to routine clinical care.
    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 Decision2017-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-14
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