GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects/Genotype 1

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GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects/Genotype 1

A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C .RecruitingA Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1

Chronic Hepatitis C C. ...Condition:Chronic Hepatitis C InfectionInterventions:Drug: GS-9190; Drug: GS-9256; Biological: Pegasys®; Drug: Copegus®; Drug: GS-9190 placebo; Drug: GS-9256 placeboThis phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.Date First Received: October 18, 2010Last Updated: October 19, 2010Verified by: Gilead Sciences, October 2010Clinical Trial Phase: Phase 2 Start Date: October 2010Overall Status:

RecruitingEstimated Enrollment: 320.Brief SummaryOfficial Title: “A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123)â€This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.Study Type: InterventionalStudy Design: Allocation: Randomized, Control: Placebo Control, Endpoint

Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: TreatmentStudy Primary Completion Date: September 2012Intervention(s) in this Clinical TrialDrug: GS-9190GS-9190 capsule, 20 mg BID, 16 or 24 weeksDrug: GS-9256GS-9256 capsule, 150 mg BID, 16 or 24 weeksBiological: Pegasys®peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeksDrug: Copegus®ribavirin 200 mg tablet (weight based: 1000 mg/day <75>/= 75 kg) divided twice daily (BID), up to 48 weeksDrug: GS-9190 placeboplacebo matching GS-9190 capsule BID, 24 weeksDrug: GS-9256GS-9256 capsule, 150 mg BID, 24 weeksBiological: Pegasys®peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeksDrug: Copegus®ribavirin 200 mg tablet (weight based:

1000 mg/day <75>/= 75 kg) divided twice daily (BID), up to 48 weeksDrug: GS-9190 placeboplacebo matching GS-9190 capsule BID, 24 weeksDrug: GS-9256 placeboplacebo matching GS-9256 capsule BID, 24 weeksBiological: Pegasys®peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeksDrug: Copegus®ribavirin 200 mg tablet (weight based: 1000 mg/day <75>/= 75 kg) divided twice daily (BID), 48 weeks.Arms, Groups and Cohorts in this Clinical TrialExperimental: Arm 1GS-9190 and GS-9256 in combination with Pegasys® and Copegus® for 16 or 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapyExperimental: Arm 2GS-9256 (active) and placebo matching GS-9190 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® may be continued for up

to 48 weeks total duration depending on individual response to therapyPlacebo Comparator: Arm 3Placebo matching GS-9190 and placebo matching GS-9256 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks totalduration.Outcome Measures for this Clinical TrialPrimary MeasuresSustained virologic response (SVR) defined as undetectable HCV RNA 24 weeks after treatment cessationTime Frame: 24 weeks of off-treatment follow-upSafety Issue?: NoSecondary MeasuresSafety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse eventsTime Frame: Through up to 48 weeks treatment period and 24 weeks of off-treatment follow-upSafety Issue?: YesEmergence of viral resistance following initiation of therapy with

GS-9190 and GS-9256Time Frame: Through up to 48 weeks treatment period, 24 weeks of off-treatment follow-up, and up to 48 weeks of follow-up in the Resistance Registry SubstudySafety Issue?: No.Viral dynamics and steady state pharmacokinetics of GS-9190 and GS-9256 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9256 over timeTime Frame: Through Week 4 of therapySafety Issue?: NoLong-term assessment of plasma HCV RNA in subjects who achieve SVRTime Frame: 36 months following Week 72Safety Issue?: NoCriteria for Participation in this Clinical TrialInclusion Criteria:Adult subjects 18 to 70 years of ageChronic HCV infection for at least 6 months prior to Baseline (Day 1)Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of

cirrhosisMonoinfection with HCV genotype 1a or 1bHCV treatment-naïveBody mass index (BMI) between 18 and 36 kg/m2Creatinine clearance >/= 50 mL/minSubject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.Screening laboratory values within defined thresholds for ALT, AST, leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium.Exclusion Criteria:Autoimmune diseaseDecompensated liver disease or cirrhosisPoorly controlled diabetes mellitusSevere psychiatric illnessSevere chronic obstructive pulmonary disease (COPD)Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotypeSuspicion of hepatocellular carcinoma or other malignancy (with exception of certain

skin cancers)History of hemoglobinopathyKnown retinal diseaseSubjects who are immunosuppressedSubjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuseSubjects who are on or are expected to be on a potent cytochrome P450 (CYP) 3A4 or Pgp inhibitor, or a QT prolonging medication within 2 weeks of Baseline (Day 1) or during the studySubjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screeningGender Eligibility for this Clinical Trial: BothMinimum Age for this Clinical Trial: 18 YearsMaximum Age for this Clinical Trial: 70 YearsAre Healthy Volunteers Accepted for this Clinical Trial?: NoClinical Trial Sponsor InformationLead Sponsor: Gilead Sciences IndustryOverall Clinical Trial Officials

and Contacts Oldach, MD Study Director Gilead SciencesOverall Contact: Brage Garofalo (650) 522-4732Additional InformationInformation obtained from ClinicalTrials.gov on October 28, 2010Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01225380Study ID Number: GS-US-196-0123ClinicalTrials.gov Identifier: NCT01225380Health Authority: United States: Food and Drug AdministrationClinical Trials Authorship and ReviewClinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org . Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health

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