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    Summary
    EudraCT Number:2012-005525-75
    Sponsor's Protocol Code Number:SSAT052
    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:2013-04-19
    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 number2012-005525-75
    A.3Full title of the trial
    An open label, randomised, pilot trial of pegylated interferon, ribavirin and telaprevir versus pegylated interferon and ribavirin alone in the response guided treatment of acute hepatitis C genotype 1 virus infection in patients with HIV-1 co-infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Peg-IFN, RBV and telaprevir vs Peg-IFN and RBV alone in patients with acute hepatitis C and HIV co-infection
    A.3.2Name or abbreviated title of the trial where available
    The addition of TPV in patients with acute hep C/HIV co-infection
    A.4.1Sponsor's protocol code numberSSAT052
    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 SponsorSt Stephen's AIDS 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 supportSt Stephen's AIDS Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt Stephen's AIDS Trust
    B.5.2Functional name of contact pointAlice Shields
    B.5.3 Address:
    B.5.3.1Street AddressRoom 1 London House
    B.5.3.2Town/ city266 Fulham Road
    B.5.3.3Post codeSW10 9EL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02033156101
    B.5.5Fax number02030550044
    B.5.6E-mailalice.shields@chelwest.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 Incivo
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameIncivo (telaprevir)
    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 INNTelaprevir
    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 number375
    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
    Acute hepatitis C infection
    E.1.1.1Medical condition in easily understood language
    Hepatitis C infection acquired within the past 6 months
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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 find out whether treating acute hepatitis C infection with PEGylated interferon, ribavirin and telaprevir gets rid of the virus as effectively as when acute hepatitis C infection is treated with PEGylated interferon and ribavirin alone
    E.2.2Secondary objectives of the trial
    To find out whether a treatment of acute hepatitis C infection with PEGylated interferon, ribavirin plus telaprevir over 12 weeks is as good as treatment with PEGylated interferon and ribavirin alone over 24 weeks, when aiming for no levels of hepatitis C virus left in the blood 24 weeks after the end of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Is male or female aged 18 years or above
    2. Has signed the Informed Consent Form voluntarily
    3. Documented current acute hepatitis C genotype 1 infection with detectable HCV-RNA (PCR-assay) with an estimated duration less than 24 weeks as defined below:
    a. HCV RNA positive AND
    b. Prior negative anti-HCV antibody or HCV RNA test within 6 months OR
    c. Rise of liver transaminases above 2.5 x ULN within the past 6 months with prior normal transaminases during the year before AND
    d. Exclusion of other causes of acute hepatitis
    4. Confirmed HIV infection
    5. Receiving a atazanavir- or efavirenz- or raltegravir-based ART regimen or able to switch regimen to these agents with an undetectable HIV viral load for at least 3 months, or not receiving ART with no immediate plans to start ART during the first 6 months of study
    6. CD4 T cell count >200/µl at screening in patients under ART, CD4 T cell count >500/µl at screening in patients without ART
    7. If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 4 months after the last dosage of ribavirin (ie 4 months after week 12, 24 or 48, depending on study arm and treatment response). Routine monthly pregnancy tests must also be performed during this time. Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
    8. Heterosexually active male participants or their female partners must use effective birth control methods (as agreed by the investigator) during the trial and for at least 7 months after the last dosage of ribavirin (ie 7 months after week 12, 24 or 48, depending on study arm and treatment response).
    E.4Principal exclusion criteria
    1. HCV infection with non-1 genotype
    2. Acute opportunistic infection requiring treatment
    3. Malignancy requiring chemotherapy or radiotherapy
    4. Active HBV infection (HBs Ag + with positive hepatitis B DNA)
    5. Known autoimmune disease
    6. Hepatic failure
    7. History of ischaemic heart disease or other serious cardiac disease
    8. Serious psychiatric disease which in the view of the investigator precludes the use of interferon
    9. Haemoglobinopathy or severe anaemia of any cause
    10. Serious abnormality on screening blood tests including, but not limited to:
    Hemoglobin <10g/dl, absolute neutrophil count <1000/mm3, platelets <90000/mm3, creatinine clearance <60ml/min
    11. If female, she is pregnant or breastfeeding
    12. Known hypersensitivity to one of the trial drugs or its excipients
    13. Other contraindicated concomitant treatment
    14. Any condition (including drug/alcohol abuse), or laboratory results which in the investigators opinion, interfere with assessments or completion of the trial
    15. Any other reason why, in the opinion of the investigator, the patient should not be enrolled in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of rates of sustained virologic response(SVR24) between treatment arms; defined as HCV RNA not detectable at 24 weeks after planned completion of therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks after end of study treatment (which may be 12, 24 or 48 weeks in duration)
    E.5.2Secondary end point(s)
    - Comparison of proportion of treated patients achieving sustained virological response after 12 weeks of therapy (SVR12) between treatment arms; defined as HCV RNA not detected at 12 weeks after planned completion of therapy.
    - Comparison of proportion of treated patients with HCV RNA not detected at the planned end of treatment (EOT) between treatment arms
    - Comparison of reduction in HCV RNA from baseline to week 4 between treatment arms
    - Comparison of change in CD4 cell count between baseline and EOT between treatment arms
    - Comparison of change in HIV RNA from baseline to EOT between treatment arms
    - Summary comparison of adverse events of grade III / IV intensity between treatment arms
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks after end of study treatment (which may be 12, 24 or 48 weeks in duration)
    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 No
    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 No
    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) 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.8.4.1Number of sites anticipated in Member State concerned1
    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 subject last visit
    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: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Continued provision of study drug is not necessary for this study, as if sustained virologic response is achieved, the patient will be considered to have cleared hepatitis C infection. If not achieved, then further treatment with the study regime would be futile.
    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 Decision2013-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-18
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