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Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

Primary Purpose

Chronic Hepatitis C Infection

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
LDV/SOF+ASV
SOF+DCV+SMV
SOF+DCV+ASV
Sponsored by
Humanity and Health Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Humanity and Health GI and Liver Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

LDV/SOF+ASV

SOF+DCV+SMV

SOF+DCV+ASV

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)

Secondary Outcome Measures

Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment.
HCV RNA levels and change during and after treatment.
Proportion of participants with on-treatment virologic breakthrough and relapse
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.

Full Information

First Posted
June 5, 2015
Last Updated
February 26, 2016
Sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital, Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02470858
Brief Title
Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects
Official Title
Effect of Triple Direct Acting Antiviral Agents (DAAs) for Non-cirrhotic Subjects With Chronic HCV G1b Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital, Emory University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LDV/SOF+ASV
Arm Type
Experimental
Arm Description
Participants with genotype 1b HCV infection will receive LDV/SOF FDC + ASV 3 weeks.
Arm Title
SOF+DCV+SMV
Arm Type
Experimental
Arm Description
Participants with genotype 1b HCV infection will receive SOF + DCV + SMV for 3 weeks.
Arm Title
SOF+DCV+ASV
Arm Type
Experimental
Arm Description
Participants with genotype 1b HCV infection will receive SOF + DCV + ASV for 3 weeks
Intervention Type
Drug
Intervention Name(s)
LDV/SOF+ASV
Other Intervention Name(s)
GS-7977, PSI-7977, GS-5885, Harvoni®, BMS-650032, Sunvepra®
Intervention Description
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.
Intervention Type
Drug
Intervention Name(s)
SOF+DCV+SMV
Other Intervention Name(s)
GS-7977, PSI-7977, Sovaldi®, BMS-790052, Daklinza®, TMC435, OLYSIO®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
SOF+DCV+ASV
Other Intervention Name(s)
GS-7977, PSI-7977, Sovaldi®, BMS-790052, Daklinza®, BMS-650032, Sunvepra®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
Description
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Time Frame
Post treatment Week 12
Title
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Time Frame
Baseline up to Week 24
Secondary Outcome Measure Information:
Title
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment.
Time Frame
Baseline up to Week 24
Title
HCV RNA levels and change during and after treatment.
Time Frame
Baseline up to Week 24
Title
Proportion of participants with on-treatment virologic breakthrough and relapse
Description
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.
Time Frame
Baseline up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Liver biopsy showing cirrhosis; Fibroscan showing cirrhosis or results>12.5 kPa ; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Lau, MD
Organizational Affiliation
Humanity and Health GI and Liver Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humanity and Health GI and Liver Centre
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
00852
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27917405
Citation
Lau G, Benhamou Y, Chen G, Li J, Shao Q, Ji D, Li F, Li B, Liu J, Hou J, Sun J, Wang C, Chen J, Wu V, Wong A, Wong CL, Tsang ST, Wang Y, Bassit L, Tao S, Jiang Y, Hsiao HM, Ke R, Perelson AS, Schinazi RF. Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study. Lancet Gastroenterol Hepatol. 2016 Oct;1(2):97-104. doi: 10.1016/S2468-1253(16)30015-2. Epub 2016 Jul 25.
Results Reference
derived

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Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

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