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    Summary
    EudraCT Number:2018-002251-14
    Sponsor's Protocol Code Number:KCHATTIC01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-11-05
    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 number2018-002251-14
    A.3Full title of the trial
    Localized on site testing and treatment of hepatitis C in homeless persons in London: a pilot non-randomised phase 4 interventional clinical trial of grazoprevir and elbasvir ± ribavirin in participants with genotype 1a, 1b or 4 to measure efficacy and adherence to treatment in a homeless population
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ATTIC - Access To Treat In the Community
    A.3.2Name or abbreviated title of the trial where available
    ATTIC - Access To Treat in the Community
    A.4.1Sponsor's protocol code numberKCHATTIC01
    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 SponsorKings College Hospital NHS Foundation Trust
    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 supportMerck, Sharpe and Dohme
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointLiver Research Office
    B.5.3 Address:
    B.5.3.1Street AddressInstitute of Liver Studies, King's COllege Hospital, Denmark Hill
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE59RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02032992038
    B.5.5Fax number02032998369
    B.5.6E-mailkosh.agarwal@nhs.net
    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 Zepatier
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameZepatier
    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 INNElbasvir
    D.3.9.1CAS number 1370468-36-2
    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 number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGrazoprevir
    D.3.9.1CAS number 1350514-68-9
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    hepatitis C viral infection
    E.1.1.1Medical condition in easily understood language
    hepatitis C infection (HCV)
    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 LLT
    E.1.2Classification code 10008914
    E.1.2Term Chronic hepatitis C without mention of hepatic coma
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the percentage of patients achieving sustained virological response (SVR 12), assessed by the percentage of participants achieving SVR [defined as HCV RNA <lower limit of quantification when tested by sensitive polymerase chain reaction (PCR)] 12 weeks after the end of all study therapy of the fixed dose combination of elbasvir and grazoprevir; given for 12 or 16 weeks in homeless persons with hepatitis C.

    2. To demonstrate the suitability of immediate diagnosis of infectious and
    progressive hepatitis C in homeless shelters; by directly testing for HCV RNA and concurrent staging of the liver disease by transient elastography (fibroscan) and APRI testing (AST to platelet ratio index).
    E.2.2Secondary objectives of the trial
    1. To demonstrate the comparable safety to other DAA treated populations
    2. To reduce the viraemic interval in infected homeless persons by introducing a short, directed testing-to-treatment pathway – to virological cure (SVR).
    3. To evaluate the safety and efficacy of this regimen in homeless participants with hepatitis C many of whom will be using drugs of potential abuse or will be on Opioid Substitution
    4. To reduce the prevalence of viraemic hepatitis C, after a pilot trial of
    treatment in three to four homeless hostels (depending upon recruitment).
    5. To evaluate participant knowledge of their hepatitis C status and willingness to engage in a test and treat protocol and to correlate the findings with demographic and sociological data
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants 18 years or older
    2. Infected with genotype 1a, 1b or 4 HCV identified on screening
    3. Able and willing to provide written informed consent.
    4. Both interferon treatment naive and experienced participants will
    be included.
    5. Participants without cirrhosis will be eligible if HCV RNA positive,
    documented chronic hepatitis C and a FibroScan of ≤ 12.5.
    6. Participants with cirrhosis (Fibroscan > 12.5 or APRI > 2) will be
    eligible if the serum albumin is > 3.5 g/dl, platelets > 100,000 and
    INR < 1.5 and there is no prior history of hepatic decompensation.
    7. Participants with well controlled HIV co-infection will be included,
    but should be stabilized on antiretrovirals for which no
    clinically significant interaction is expected.
    8. Participants who are HBsAg positive will be included but will require antiviral
    prophylaxis for hepatitis B. Anti-HBc positive participants will be
    included; prophylaxis will not be given but these clients will require
    close monitoring of their ALT elevations
    E.4Principal exclusion criteria
    1. Persons with prior HCV DAA treatment will be excluded.
    2. Clinically-significant medical or psychiatric illness (other than chronic HCV) in the past,
    present, or being evaluated, that may interfere with participant treatment, safety,
    assessment or compliance with the protocol
    3. Participants with active TB infection will be excluded.
    4. Refusal to practice effective contraception.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be the percentage of participants achieving an SVR, defined as an HCV RNA level less than the lower limit of quantification by sensitive PCR; by means of a short directed test and treat program in the homeless community.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation will be done at end of study (end of all clinical interventions as specified in the protocol)
    E.5.2Secondary end point(s)
    1. Reduction in local prevalence of of viraemic hepatitis C, after a pilot trial of treatment in three to four homeless hostels.
    2. Participant knowledge of their hepatitis C status and willingness to engage in a test and treat protocol and correlation of these findings with demographic and sociological data.
    3. Impact of a localized test and treat protocol on health related quality of life.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation will be done at end of study (end of all clinical interventions as specified in the protocol)
    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 Yes
    E.6.13.1Other scope of the trial description
    feasibility of method of delivery of treatment in the community i.e treatment pathway
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 months3
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    This will not be applicable. Patients will complete treatment within the study period.
    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 Decision2018-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-11-30
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