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    Summary
    EudraCT Number:2016-000599-87
    Sponsor's Protocol Code Number:011094
    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:2016-04-27
    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 number2016-000599-87
    A.3Full title of the trial
    Response guided therapy with daclatasvir, sofosbuvir and ribavirin for 12 or 24 weeks in patients with genotype 3 chronic hepatitis C virus: is longer therapy worthwhile?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment for type 3 chronic hepatitis C virus infection: comparing 12 and 24 weeks of antiviral drugs - is longer therapy worthwhile?
    A.3.2Name or abbreviated title of the trial where available
    Extend-3 v2.7 (19.5.16)
    A.4.1Sponsor's protocol code number011094
    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 SponsorQueen Mary University of London
    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 supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQueen Mary University of London
    B.5.2Functional name of contact pointDr Sally Burtles
    B.5.3 Address:
    B.5.3.1Street AddressJoint Research Management Office, QM Innovation Building, 5 Walden Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeE1 2EF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02078827260
    B.5.6E-mailsponsorsrep@bartshealth.nhs.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 Epclusa
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEpclusa
    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 INNsofosbuvir
    D.3.9.4EV Substance CodeAS11
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvelpatasvir
    D.3.9.4EV Substance CodeAS12
    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.3.9.4EV Substance CodeAS13
    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
    Adult patients chronically infected with genotype 3 hepatitis C virus with cirrhosis
    E.1.1.1Medical condition in easily understood language
    Adults infected with hepatitis C virus (subtype 3) causing severe liver scaring and damage
    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
    This trial will study the treatment effectiveness of sofosbuvir/velpatasvir for 12 or 24 weeks, in patients infected with genotype 3 hepatitis C virus, with advanced liver disease (cirrhosis), who are slow responders to treatment with persistent virus after the first two weeks of treatment.

    This trial will answer if identifying patients by their viral response during treatment (whether the virus is cleared after the first two weeks) can guide the duration of therapy required to achieve cure.
    E.2.2Secondary objectives of the trial
    This study will compare the tolerability and side effects experienced by patients treated with 12 or 24 weeks of sofosbuvir/velpatasvir. Specifically it will study the frequency of serious adverse events and requirements for stopping treatment prematurely. The study will evaluate quality of life following treatment, using a standardised questionnaire.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Voluntarily signed informed consent form
    • Aged 18 years or older
    • Chronic HCV infection, defined by anti-HCV antibody or HCV RNA detection for greater than 6 months
    • Infected with genotype 3 HCV (identified by referring hospital)
    • Meets NHS England treatment criteria to commence sofosbuvir/velpatasvir
    • Pre-treatment HCV RNA >10,000 iu/mL (can be any time before treatment week 0)
    • HCV RNA > or equal to 30 iu/mL at treatment week 2 (+/- 3 days)
    • Has cirrhosis defined by: evidence of portal hypertension, OR APRI >2 plus AST:ALT ratio >1, OR radiological evidence of cirrhosis, OR fibroscan score >11.5kPa, OR liver biopsy showing cirrhosis
    • Patients with decompensated cirrhosis (variceal bleeding, ascites and encephalopathy) can be included
    • Patients with malignancy including hepatocellular carcinoma can be included
    • Patients with liver transplant can be included
    • Patients coinfected with chronic hepatitis B virus or human immunodeficiency virus can be included
    • Female subjects of childbearing potential must have documented negative pregnancy test prior to enrolment (negative urinary pregnancy test), and if engaged in heterosexual intercourse must use protocol specified method of contraception (see below) during study drug treatment and for 30 days after last dose
    • Male subjects engaged in heterosexual intercourse with a female of childbearing potential should protocol specified method of contraception during study drug treatment and for 30 days after last dose
    E.4Principal exclusion criteria
    • Any of the above inclusion criteria not met
    • Any of the following criteria excludes a subject from enrolling into this study
    • 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.
    • Severe renal impairment with eGFR <30 mL/min/1.73m2 or requiring dialysis
    • Alcohol consumption or illicit drug abuse likely to interfere with participant treatment, safety, assessment or compliance with protocol, as deemed by the investigator
    • Previous exposure to sofosbuvir (or other NS5B inhibitor) or NS5A inhibitor
    • Severe allergy to study drugs, its metabolites or formulation excipient (see SmPC for details)
    • Any investigational medicinal product ≤ 6 weeks prior to treatment start
    • Pregnant or nursing female, or males wishing to conceive during the period of study treatment + 30 days after
    • Patients who adhered to less than 90% of prescribed sofosbuvir/velpatasvir at screening
    • In accordance with the SmPC of sofosbuvir/velpatasvir concomitant use of the following medications are contraindicated:

    Anticonvulsants - carbamazepine, phenytoin, phenobarbital, oxcarbazepine
    Antimycobacterials – rifampicin, rifabutin, rifapentine
    Antiretrovirals - efavirenz
    St John’s wort
    Modafinil
    Proton-pump inhibitors should be avoided and if necessary, should be administered 4 hours after at maximum doses equivalent to 20mg omeprazole per day.
    Amiodarone should be avoided and if necessary, close monitoring is required

    Please consult the SmPC and Section 15.16 and 17 for list of medications to be used with caution or monitoring.

    Participants taking these medications must have discontinued prior to starting sofosbuvir/velpatasvir (this is expected to be in line with standard care practice). Definition of child-bearing potential and effective contraception:

    Subjects are considered not of child-bearing potential if they are surgically sterile (undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (women aged ≥ 45 years of age with cessation of previously occurring menses for ≥ 12 months) or they have medically-documented ovarian failure.

    Effective contraception include:
    • True abstinence: when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence, e.g. calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception)
    • Male partner vasectomy or other medical condition causing azoospermia
    • Male partner using condom
    • Intrauterine device
    • Female barrier method (cervical cap or diaphragm with spermicidal agent)
    • Tubal sterilisation
    • Levonorgestrel implant
    • Injectable progesterone
    • Oral contraceptive (combined or progesterone only)
    • Contraceptive vaginal ring
    • Transdermal contraceptive patch
    E.5 End points
    E.5.1Primary end point(s)
    To compare the efficacy (the proportion of randomised patients who achieve a sustained virological response – defined as undetectable HCV RNA (below limit of quantification up to 15 iu/mL) at 12 weeks (up to 16 weeks) after end of treatment – SVR12) of 12 OR 24 weeks of sofosbuvir/velpatasvir in patients with genotype 3 chronic HCV and cirrhosis, who have detectable viraemia (≥ 30 iu/mL) at week 2 (+/- 3 days) of treatment with sofosbuvir/velpatasvir.

    Patients randomised must have completed at least 90% of sofosbuvir/velpatasvir at screening, and patients randomised to 24 weeks must have taken at least one dose of the extension phase treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks post completion of treatment (whether 12 or 24 weeks in total)
    E.5.2Secondary end point(s)
    To assess the safety and tolerability of sofosbuvir/velpatasvir for 12 and 24 weeks.

    To assess patient reported outcomes (defined as SF36 scores at the end of therapy) in patients receiving 12 or 24 weeks of sofosbuvir/velpatasvir
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks post completion of treatment (whether 12 or 24 weeks in total)
    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
    response-guided therapy: utility of on treatment virus response to guide duration of treatment
    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 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
    duration of treatment - 24 weeks (test treatment) compared to 12 weeks (standard of care treatment)
    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 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
    3 months after the last visit of the last subject, which allows for data collation and analysis.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    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: 50
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 60
    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 are returned to their usual clinician for ongoing care at the end of the trial.
    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 Decision2016-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-04-04
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