Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients

March 16, 2018 updated by: Humanity and Health Research Centre

Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 2 Infection

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 4

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
    • Beijing
      • Beijing, Beijing, China, 100039
        • Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
    • 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:

  1. Age equal to or greater than 18 years, with chronic genotype 2 HCV infection;
  2. Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
  3. HCV RNA > 10,000 IU/mL at Screening;
  4. Screening laboratory values within defined thresholds
  5. Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  1. Pregnant or nursing female or male with pregnant female partner;
  2. HIV or chronic hepatitis B virus (HBV) infection;
  3. Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
  4. Active or recent history (≤ 1 year) of drug or alcohol abuse;
  5. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).

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: SOF+RBV 8 wk
Participants will receive SOF+RBV for 8 weeks.
Drug: SOF+RBV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other Names:
  • Copegus®
  • Sovaldi®
  • GS-7977
  • PSI-7977
Experimental: SOF+RBV 12 wk
Participants will receive SOF+RBV for 12 weeks.
Drug: SOF+RBV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other Names:
  • Copegus®
  • Sovaldi®
  • GS-7977
  • PSI-7977
Experimental: SOF+DCV 8 wk
Participants will receive SOF+DCV for 8 weeks.
Drug: SOF+DCV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
  • BMS-790052
  • Daklinza®
Experimental: SOF+DCV 12 wk
Participants will receive SOF+DCV for 12 weeks.
Drug: SOF+DCV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
  • BMS-790052
  • Daklinza®
Experimental: LDV/SOF 8 wk
Participants will receive LDV/SOF for 8 weeks.
Drug: LDV/SOF
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-7977/GS-5885
Experimental: LDV/SOF 12 wk
Participants will receive LDV/SOF for 12 weeks.
Drug: LDV/SOF
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-7977/GS-5885

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
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

Beijing 302 Hospital

Investigators

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

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 31, 2017

Study Completion (Actual)

March 15, 2018

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H&H_HCV G2 Study

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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