Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

February 26, 2016 updated by: Humanity and Health Research Centre

Effect of Triple Direct Acting Antiviral Agents (DAAs) for Non-cirrhotic Subjects With Chronic HCV G1b Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China, 00852
        • Humanity and Health GI and Liver Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Harvoni®
  • GS-7977
  • PSI-7977
  • BMS-650032
  • Sunvepra®
  • GS-5885
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:
  • Sovaldi®
  • GS-7977
  • PSI-7977
  • BMS-790052
  • TMC435
  • OLYSIO®
  • Daklinza®
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:
  • Sovaldi®
  • GS-7977
  • PSI-7977
  • BMS-790052
  • BMS-650032
  • Sunvepra®
  • Daklinza®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Time Frame: Baseline up to Week 24
Baseline up to Week 24
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
Time Frame: Post treatment Week 12
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Post treatment Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment.
Time Frame: Baseline up to Week 24
Baseline up to Week 24
HCV RNA levels and change during and after treatment.
Time Frame: Baseline up to Week 24
Baseline up to Week 24
Proportion of participants with on-treatment virologic breakthrough and relapse
Time Frame: 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.
Baseline up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanity and Health Research Centre

Collaborators

Emory University
Beijing 302 Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H&H_Triple Therapy_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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