Clinical trial NCT02470858: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Infection
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
name: Emory University
First posted: 2015-06-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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.

Primary outcomes:
measure: Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
timeFrame: Post treatment Week 12
measure: Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
timeFrame: Baseline up to Week 24
Secondary outcomes:
measure: Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment.
timeFrame: Baseline up to Week 24
measure: HCV RNA levels and change during and after treatment.
timeFrame: Baseline up to Week 24
measure: Proportion of participants with on-treatment virologic breakthrough and relapse
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Humanity and Health GI and Liver Centre
state: Hong Kong
Study officials:
affiliation: Humanity and Health GI and Liver Centre
name: George Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.