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Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

Sponsor
Humanity and Health Research Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02470858
Collaborator
Beijing 302 Hospital (Other), Emory University (Other)
18
Enrollment
1
Location
3
Arms
11
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Triple Direct Acting Antiviral Agents (DAAs) for Non-cirrhotic Subjects With Chronic HCV G1b Infection
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: LDV/SOF+ASV

Participants with genotype 1b HCV infection will receive LDV/SOF FDC + ASV 3 weeks.

Drug: LDV/SOF+ASV
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.
Other Names:
  • GS-7977
  • PSI-7977
  • GS-5885
  • Harvoni®
  • BMS-650032
  • Sunvepra®

    		•
    Experimental: SOF+DCV+SMV

    Participants with genotype 1b HCV infection will receive SOF + DCV + SMV for 3 weeks.

    Drug: SOF+DCV+SMV
    Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
    Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
  • BMS-790052
  • Daklinza®
  • TMC435
  • OLYSIO®

    		•
    Experimental: SOF+DCV+ASV

    Participants with genotype 1b HCV infection will receive SOF + DCV + ASV for 3 weeks

    Drug: SOF+DCV+ASV
    Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.
    Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
  • BMS-790052
  • Daklinza®
  • BMS-650032
  • Sunvepra®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [Post treatment Week 12]

      SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.

    2. Proportion of participants with adverse events leading to permanent discontinuation of study drug(s) [Baseline up to Week 24]

    Secondary Outcome Measures

    1. Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment. [Baseline up to Week 24]

    2. HCV RNA levels and change during and after treatment. [Baseline up to Week 24]

    3. Proportion of participants with on-treatment virologic breakthrough and relapse [Baseline up to Week 24]

      Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age equal to or greater than 18 years, with chronic genotype 1b HCV infection;

    • HCV RNA level > 10,000 and < 10,000,000 IU/ml at Screening;

    • Rapid response to triple DAAs therapy with less than 500 IU/ml plasma HCV RNA level at Day 2;

    • No evidence of cirrhosis. Cirrhosis defined as any 1 of the following, within 6 months of study entry:

    1. Liver biopsy showing cirrhosis;

    2. Fibroscan showing cirrhosis or results>12.5 kPa ;

    3. FibroTest® score >0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) >2 during screening.

    Exclusion Criteria:

    • Pregnant or nursing female or male with pregnant female partner;

    • HIV or chronic hepatitis B virus (HBV) infection;

    • Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;

    • Active or recent history (≤ 1 year) of drug or alcohol abuse;

    • Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers);

    • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Humanity and Health GI and Liver Centre Hong Kong Hong Kong China 00852

    Sponsors and Collaborators

    • Humanity and Health Research Centre
    • Beijing 302 Hospital
    • Emory University

    Investigators

    • Principal Investigator: George Lau, MD, Humanity and Health GI and Liver Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Humanity and Health Research Centre
    ClinicalTrials.gov Identifier:
    NCT02470858
    Other Study ID Numbers:
    • H&H_Triple Therapy_1
    First Posted:
    Jun 12, 2015
    Last Update Posted:
    Mar 1, 2016
    Last Verified:
    Feb 1, 2016
    Additional relevant MeSH terms:
    Infections
    Hepatitis C
    Hepatitis C, Chronic
    Sofosbuvir
    Asunaprevir

    Study Results

    No Results Posted as of Mar 1, 2016