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Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470858
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : March 1, 2016
Sponsor:
Collaborators:
Beijing 302 Hospital
Emory University
Information provided by (Responsible Party):
Humanity and Health Research Centre

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
Chronic Hepatitis C Infection Drug: LDV/SOF+ASV Drug: SOF+DCV+SMV Drug: SOF+DCV+ASV Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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®




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470858


Locations
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China, Hong Kong
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
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Principal Investigator: George Lau, MD Humanity and Health GI and Liver Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Humanity and Health Research Centre
ClinicalTrials.gov Identifier: NCT02470858    
Other Study ID Numbers: H&H_Triple Therapy_1
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Infection
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Sofosbuvir
Asunaprevir
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action