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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   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:2008-007456-96
    Sponsor's Protocol Code Number:GS-US-227-0106
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-007456-96
    A.3Full title of the trial
    A Phase 2b, Double blind, Randomized, Parallel Group, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GS 9450 in Adults with Chronic Hepatitis C Virus Infection
    A.4.1Sponsor's protocol code numberGS-US-227-0106
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGilead Sciences, Inc
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameGS-9450
    D.3.2Product code GS-9450
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGS-9450
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.3.1Product nameGS-9450
    D.3.2Product code GS-9450
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGS-9450
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    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 efficacy of two oral doses of GS 9450 to placebo in subjects with chronic HCV infection as evidenced by histologic response (at least a 2-point decrease in Knodell necroinflammatory score with no concurrent worsening in the Knodell fibrosis score) at Week 24.
    E.2.2Secondary objectives of the trial
    • To compare the safety and tolerability of two oral doses of GS 9450 to placebo in subjects with chronic HCV
    • To compare the efficacy of two oral doses of GS 9450 to placebo in subjects with chronic HCV, as evidenced by:
    — Change from baseline in the Knodell necroinflammatory score
    — Change from pretreatment in alanine aminotransferase (ALT) levels;
    — Change from pretreatment in aspartate aminotransferase (AST) levels;
    — Change from baseline in CK–18 caspase cleavage fragments;
    — Change from baseline in hepatic collagen content as measured by morphometry of liver biopsy specimens;
    — Evaluation of Ishak scoring relative to baseline;
    — Change from baseline in hepatic apoptosis as measured by TUNEL staining of liver biopsy specimens; and
    — Change from baseline in hepatic CK–18 neoantigen expression as measured by immunohistochemical staining of liver biopsy specimens
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female, aged from 18 to 65 years old, inclusive
    • Chronic HCV infection, defined as having documented HCV infection (antibody or RNA positivity) at least 6 months prior to Baseline (Day 1) with HCV viremia (i.e., detectable plasma HCV RNA levels) at screening
    • Documented evidence of either 1) having previously failed treatment with PEG-based HCV therapy in combination with RIBA therapy, OR 2) being unable to tolerate or having contraindications to receiving INF or RIBA therapy
    •Have a Knodell necroinflammatory score at least 3 as determined from the screening liver biopsy evaluation
    • Have laboratory values at Screen that meet the following criteria:
    - ALT >ULN but < 10 x ULN;
    - AST < 10 x ULN;
    - platelets at least 75,000/mm3;
    - total bilirubin less than or equal to 1.5 x ULN;
    - prothrombin time less than or equal to 1.5 x ULN;
    - albumin at least 3.0 g/dL;
    - absolute neutrophil count (ANC) at least 1,000 cells/mm3 (Note: physiologic neutropenia may be allowed subsequent to GSI Medical Monitor review and approval); and
    - hemoglobin (Hb) at least 10 g/dL
    • Have a BMI between 19 and 36 kg/m2, inclusive
    • Creatinine clearance (CLcr) at least 70 mL/min
    • Heterosexually active males must be willing to use a highly effective method of contraception from Screen for at least 3 months (90 days) after receiving the last dose of study drug. Males must also agree not to donate sperm for at least 3 months (90 days) after the last study drug dose(s).
    • Females who are < 60 years old (testing not required for those who have had a hysterectomy, tubal ligation, or bilateral oophorectomy) must have a negative serum pregnancy test at Screen and a negative urine pregnancy test at Baseline prior to receiving the first dose of study drug. Females of childbearing potential must agree to use an acceptable highly effective method of contraception during heterosexual intercourse from Screen through at least 30 days or one menstrual cycle (whichever is longer) after receiving the last dose of study drug. Female subjects currently using hormonal contraception must have used that method of hormonal contraception for at least 3 months prior to enrolling in the study and must agree to continue using their existing hormonal contraception and supplement it with a barrier method of contraception
    • In reasonably good health as determined by the Investigator, based on review of the results of a screening evaluation (to include physical examination, vital signs and routine clinical laboratory tests)
    • Willing and able to provide written, informed consent
    E.4Principal exclusion criteria
    • Pregnant or breast feeding women or women who believe they may wish to become pregnant during the course of the study or within 30 days or one menstrual cycle (whichever is longer) of last study drug administration
    • Males who have partners planning to become pregnant during the course of the study or within 90 days of the last dose of study drug
    • Females and males of reproductive potential who are unwilling to use effective method(s) of birth control while enrolled in the study and for a minimum of 30 (or one menstrual cycle, whichever is longer) or 90 days, respectively, after ingestion of the last dose of study medication
    • Infection with HCV genotype 3
    • Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) or other liver disease of a non-HCV etiology
    • Presence of pancreatitis
    • History of solid organ transplantation
    • Presence of autoimmune disease
    • History of malignancy (history of localized squamous or non-invasive basal cell skin cancers successfully treated more than 5 years from screening is permitted)
    • Current excessive alcohol ingestion, averaging > 3 drinks/day for females and > 4 drinks/day for males or binge drinking
    • History of seizure, including a single episode
    • Is a public transportation operator or operates heavy construction machinery
    • Recent significant infection
    • History of or current evidence of hepatocellular carcinoma (HCC; e.g., a-fetoprotein > 50 ng/mL or as indicated by recent imaging) [ultrasound or triple-phase IV contrast CT/MRI] performed within 3 months prior to screening or, if recent imaging has not been performed, prescence of hepatic nodule on screening right upper quadrant [RUQ] ultrasound that is consistent with a diagnosis of HCC)
    • Decompensated liver disease, as indicated by total bilirubin > 1.5 x ULN, prothrombin time > 1.5 x ULN, platelets < 75,000/mm3 or albumin < 3 g/dL at screening OR current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage)
    • Presence of Child-Pugh grade B or C cirrhosis
    • Hb < 10 g/dL at Screen
    • ANC < 1,000 cells/mm3 at Screen
    • Have initiated therapy with agents having potential hepatic anti-inflammatory or anti-fibrotic properties within 90 days prior to Baseline (Day 1) or are expected to initiate such therapy during the study. Such agents include (but are not limited to): angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, peroxisome proliferator-activated receptor agonists, ursodeoxycholic acid, mycophenolate, pentoxifylline. Subjects who have received such agents may be eligible if they have received stable therpay (including dose) for ≥ 90 days prior to Baseline (Day 1) and are anticipated to continue therapy throughout the study; consultation with the GSI Medical Monitor is required prior to enrollment of such subjects
    • Have initiated therapy with potentially hepatotoxic/cholestatic drugs within 90 days prior to Baseline or are expected to initiate such therapy during the study
    Subjects who have received such agents may be eligible if they have received stable therapy (including dose) for at least 90 days prior to Baseline and are anticipated to continue therapy throughout the study. Intermittent use of acetaminophen in recommended doses is permitted
    • Are expected to receive an anti-tuberculosis medication at anytime during the study
    • Have received therapy with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 90 days prior to Baseline or are expected to receive such therapy during the study
    • Have initiated maintainance therapy with or have been non-compliant with a treatment regimen of methadone or buprenorphine within six months prior to Baseline (Day 1) or are expected to initiate such therapy during the study
    • Are expected to receive anti-HCV therapy from Baseline (Day 1) to week 24 study visit.
    • Have received prescribed medications that are known to increase the risk of seizure within 30 days prior to Baseline (Day 1) or are expected to receive such therapy during the study
    • History of or current clinically significant illness or any other major medical disorder that may interfere with subject treatment, assessment, compliance with the protocol or adequate follow-up
    • Have a history of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
    • Received study medication while participating in another research study within 60 days prior to Baseline
    • A positive urine drug screen for amphetamines or cocaine at Screen
    • Known hypersensitivity to the study drugs, the metabolites or formulation excipients
    E.5 End points
    E.5.1Primary end point(s)
    Histologic response (at least 2 point decrease in Knodell necroinflammatory score with no concurrent worsening in the Knodell fibrosis score) at Week 24.
    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 Yes
    E.6.7Pharmacodynamic No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    LPLV will be defined as date of last Week 28 follow-up visit for the last patient
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) No
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 330
    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)
    Subjects will be treated according to current standard of care, which will be the responsibility of the primary treating physician
    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 Decision2009-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-07-20
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