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Completed

NCT Number: NCT02470858

Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

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.

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Key information

Conditions

Chronic Hepatitis C Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Humanity and Health GI and Liver Centre

Hong Kong, 00852, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LDV/SOF+ASV

Drug

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®

SOF+DCV+SMV

Drug

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®

SOF+DCV+ASV

Drug

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®

Primary outcomes

  1. 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.

  2. Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)

    Time frame: Baseline up to Week 24

Secondary outcomes

  1. Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment.

    Time frame: Baseline up to Week 24

  2. HCV RNA levels and change during and after treatment.

    Time frame: Baseline up to Week 24

  3. 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.

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Collaborators

  • Beijing 302 Hospital
  • Emory University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2015
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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