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    Summary
    EudraCT Number:2012-000523-40
    Sponsor's Protocol Code Number:HAI115879
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-20
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-000523-40
    A.3Full title of the trial
    A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antiviral Effect of GSK2336805 With Pegylated Interferon and Ribavirin in Patients with Chronic Hepatitis C Infection.
    A.4.1Sponsor's protocol code numberHAI115879
    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 SponsorGlaxoSmithKline Research and Devlopment Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGSK
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402089904466
    B.5.5Fax number+4402089901234
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    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.3.2Product code GSK2336805
    D.3.4Pharmaceutical form 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 INNGSK2336805
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeGSK2336805
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 2
    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.3.2Product code GSK2336805
    D.3.4Pharmaceutical form 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 INNGSK2336805
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeGSK2336805
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 virus
    E.1.1.1Medical condition in easily understood language
    Chronic 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 LLT
    E.1.2Classification code 10019752
    E.1.2Term Hepatitis C virus (HCV)
    E.1.2System Organ Class 10022891 - Investigations
    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 objectives of this study are:
    • To evaluate the 12-week safety and tolerability of 40 and 60 mg of GSK2336805 when given in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA).
    • To evaluate 12-week antiviral activity of 40 and 60 mg of GSK2336805 when given in combination with PEG and RIBA as measured by eRVR (defined as undetectable plasma HCV RNA at Weeks 4 and 12)
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are:
    • To evaluate the safety and tolerability of 40 and 60 mg of GSK2336805 when given in combination with PEG (pegylated interferon alfa-2a) and RIBA (ribavirin) for 12 weeks, followed by either 12 or 36 weeks of combination therapy with PEG and RIBA based on RGT
    • To describe GSK2336805 plasma pharmacokinetics at 40- and 60-mg dose levels when given in combination with PEG and RIBA
    • To compare very rapid virologic response (vRVR) rates defined as undetectable plasma HCV RNA 2 weeks after initiation of therapy)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    2. Is male or female aged 18 to 70 years, inclusive, at Screening.
    3. Has chronic genotype 1 or genotype 4 (as assessed by VERSANT HCV Genotype assay 2.0 (LiPA); Siemens Healthcare Diagnostics, Deerfield, Illinois) HCV infection documented by at least 1 measurement of serum HCV RNA ≥100,000 IU/mL measured during Screening by the COBAS High Pure/COBAS
    TaqMan HCV Test v2.0 (Roche Molecular Diagnostics, Pleasanton, California) and at least one of the following:
    • A positive anti-HCV antibody, HCV RNA, or HCV genotype test at least 6 months prior to Baseline (Day 1) together with positive HCV RNA and anti-HCV antibody tests at the time of Screening; or
    • A positive HCV RNA test and anti-HCV antibody test at the time of Screening together with either a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis).
    4. Is naïve to all HCV antiviral treatment(s), including, but not limited to, immunomodulatory and nucleoside/nucleotide treatments for chronic HCV infection.
    5. Agrees to IL28B genotyping.
    6. Is a subject, who, in the opinion of the investigator, is an appropriate candidate for PEG/RIBA/protease inhibitor combination therapy for genotype 1 subjects and PEG/RIBA combination therapy for genotype 4 subjects.
    7. Has a body mass index >18 kg/m2 but not exceeding 36 kg/m2.
    8. Has a liver biopsy obtained within 3 years (36 calendar months) prior to the Day 1 visit, with a fibrosis classification of noncirrhotic as judged by a local pathologist (defined as Knodell ≤3, Metavir ≤2, Ishak ≤4, or Batts and Ludwig ≤2). Both incomplete and transition to cirrhosis (e.g., Metavir score 3) are considered as
    cirrhosis. If no recent (<36 months) liver biopsy is available, a study-qualifying biopsy must be performed prior to Baseline (Day 1).
    9. For all fertile males and females, must use 2 forms of effective contraception (as defined in inclusion criterion #10) between them during treatment and during the 24 weeks after treatment ends.
    10. For females, is eligible to enter and participate in the study if she is of
    • Nonchildbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who
    • Has had a hysterectomy
    • Has had a bilateral oophorectomy (ovariectomy)
    • Has had a bilateral tubal ligation
    • Is postmenopausal (demonstrate total cessation of menses for greater than 1 year)
    • Childbearing potential and has a negative urine or serum pregnancy test at Screening and within the 24-hour period prior to the first dose of study medication and completely abstains from intercourse for 2 weeks before exposure to the study medication, throughout the clinical study, and for
    24 weeks after completion or premature discontinuation from this study or uses 2 of the following acceptable methods of contraception throughout the clinical study and for 24 weeks after completion or premature discontinuation from this study:*
    • Any intrauterine device with a documented failure rate of <1% per year
    • Double-barrier contraception (condom, diaphragm, or cervical cap used with spermicidal jelly)
    • Male partner who is sterile prior to the female subject’s study entry and is the sole sexual partner for that female
    • Any other contraceptive method with a documented failure rate of <1% per year
    11. Is otherwise healthy as determined by the medical history, physical examination, ECG findings, and clinical laboratory measurements performed at Screening.
    French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    E.4Principal exclusion criteria
    1. Has positive test at Screening for hepatitis B surface antigen (HBsAg) or antihuman immunodeficiency virus antibody.
    2. Has a history of any other clinically significant chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson's disease, 1-antitrypsin deficiency, alcoholic liver disease, >Grade 1 nonalcoholic steatohepatitis, and toxin exposures) (Note: Subjects with Gilbert’s syndrome who otherwise meet all inclusion/exclusion criteria are eligible.)
    3. Has a history of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease.
    4. Has positive results on urine screen for drugs of abuse test at Screening (unless used as medical treatment, e.g., with a prescription).
    5. Has a history of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation program).
    6. Has screening ECG corrected QT (QTc) interval value >450 ms and/or clinically significant ECG findings.
    7. Has personal or family history of torsade de pointes findings.
    8. Is pregnant or nursing.
    9. Is male with a female partner who is pregnant.
    10. Has abnormal hematological and biochemical parameters, including:
    • Neutrophil count <1500 cells/mm3 (or <1250 cells/mm3 for African
    American/Black subjects)
    • Hemoglobin <11 g/dL in females or <12 g/dL in males
    • Creatinine ≥1.5 × the upper limit of normal (ULN)
    • Estimated creatinine clearance ≤50 mL/min (as calculated using the Cockcroft-Gault formula)
    • ALT, AST, or alkaline phosphatase ≥5 × ULN
    • Total bilirubin ≥2.0 × ULN (except subjects with Gilbert's syndrome)
    • Albumin ≤3.0 g/dL
    • Platelet count ≤90,000/mm3
    11. Has history of major organ transplantation with an existing functional graft.
    12. Has thyroid dysfunction not adequately controlled.
    13. Has a history of any one of the following:
    • Suicide attempt or hospitalization for depression in the past 5 years
    • Any current (within 6 months) severe or poorly controlled psychiatric disorder
    • The following subjects are eligible for study participation but must be assessed
    and followed (if recommended) by a mental health professional:
    • Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago
    14. Has a history or current evidence of immunologic disorder; cardiac or pulmonary disease; seizure disorder; or cancer or history of malignancy that in the opinion of the investigator makes the subject unsuitable for the study.
    15. Has been treated with herbal or natural remedies with antiviral activity within 30 days of the baseline visit or has a history of having received any systemic antineoplastic or immunomodulatory treatment (including mycophenolate mofetil, thymosin alpha, supraphysiologic doses of steroids >10 mg/day and radiation) within 6 months of the baseline visit or expects that such treatment will be needed at any time during the study.
    16. Has participated in a clinical study with an investigational drug, biologic, or device within 3 months prior to the first dose administration.
    17. Has a history of a known allergy to antiviral medications, including telaprevir, PEG, or RIBA, or any excipient in the investigational product or history of drug or other allergy that, in the opinion of the investigator, contradicts participation.
    18. Requires prohibited medications.
    E.5 End points
    E.5.1Primary end point(s)
    • Assessment of 12-week safety and tolerability as measured by the nature and frequency of AEs and absolute values and changes over time from predose
    values for hematology, clinical chemistry, urinalysis, vital sign measurements (blood pressure, heart rate), and ECG parameters
    • Proportion of subjects achieving eRVR (extended rapid virological response)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    • To evaluate the safety and tolerability of 40 and 60 mg of GSK2336805 when given in combination with PEG and RIBA for 12 weeks, followed by either 12 or 36 weeks of combination therapy with PEG and RIBA based on RGT (response guided treatment)
    • To describe GSK2336805 plasma pharmacokinetics at 40- and 60-mg dose levels when given in combination with PEG and RIBA
    • To compare very rapid virologic response (vRVR) rates defined as undetectable plasma HCV RNA 2 weeks after initiation of therapy)
    • To compare RVR rates (defined as undetectable plasma HCV RNA 4 week after initiation of therapy)
    • To compare complete early virologic response (cEVR) rates (defined as undetectable plasma HCV RNA 12 weeks after initiation of therapy)
    • To compare 12-week sustained virologic response (SVR12) rates (defined as undetectable plasma HCV RNA 12 weeks after completion of all therapy)
    • To compare the 24-week sustained virologic response (SVR24) rates (defined as undetectable plasma HCV RNA 24 weeks after completion of all therapy)
    • To compare SVR rates among subjects who receive a total of 24 weeks of therapy (12 weeks of GSK2336805 and PEG + RIBA followed by 12 weeks of PEG + RIBA) versus those who receive the current SoC (PEG + RIBA and telaprevir based on label recommendations)
    • To evaluate the potential of HCV to develop resistance against GSK2336805 by repeated sequencing of HCV strains
    • To further characterize the antiviral activity and safety of GSK2336805 in subjects with chronic genotype 4 HCV infection (Note: for the final reporting, the data from this cohort may be combined with the data from the cohort of genotype 1 subjects as appropriate)
    • To describe exposure-response relationships of GSK2336805 (e.g., the relationship between GSK2336805 dose or plasma exposure and measures of virologic response) when given in combination with PEG + RIBA
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 4, 12, 24, 48, 60, and 72
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dose-Ranging
    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 trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Puerto Rico
    United States
    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’s Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 98
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 115
    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)
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the subject’s medical condition whether or not GSK is providing specific poststudy treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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