Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 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 3 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 genotype 3 infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 3

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:

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

Exclusion Criteria:

  • Pregnant or nursing female;
  • HIV infection or HBV infection (HBcAb and HBsAg positive);
  • 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).

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
Active Comparator: Sofosbuvir and Daclatasvir
Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.
Drug: sofosbuvir and daclatasvir
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
  • BMS-790052
  • Daklinza®
Active Comparator: Ledipasvir/sofosbuvir
Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks.
Drug: ledipasvir/sofosbuvir

Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally.

once daily;

Other Names:
  • Harvoni®
  • GS-7977
  • PSI-7977
  • GS-5885

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy
Time Frame: Post treatment Week 12
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication
Post treatment Week 12
Incidence of adverse events leading to permanent discontinuation of study drug
Time Frame: Baseline up to Week 12
Baseline up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence
Time Frame: Baseline to Week 12
To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)
Baseline to Week 12
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
Time Frame: Baseline up to Week 12
Baseline up to Week 12
HCV RNA levels and change during and after treatment
Time Frame: Baseline up to Week 12
Baseline up to Week 12
Change in health related quality of life
Time Frame: Baseline to Week 24
To evaluate the change in health-related quality of life during treatment
Baseline 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 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

May 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

March 15, 2018

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 15, 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 G3 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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