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

Primary Purpose

Chronic Hepatitis C Infection

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
SOF+RBV
SOF+DCV
LDV/SOF
Sponsored by
Humanity and Health Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
  • Humanity and Health GI and Liver Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

SOF+RBV 8 wk

SOF+RBV 12 wk

SOF+DCV 8 wk

SOF+DCV 12 wk

LDV/SOF 8 wk

LDV/SOF 12 wk

Arm Description

Participants will receive SOF+RBV for 8 weeks.

Participants will receive SOF+RBV for 12 weeks.

Participants will receive SOF+DCV for 8 weeks.

Participants will receive SOF+DCV for 12 weeks.

Participants will receive LDV/SOF for 8 weeks.

Participants will receive LDV/SOF for 12 weeks.

Outcomes

Primary Outcome Measures

Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)

Secondary Outcome Measures

Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
HCV RNA levels and change during and after treatment.
Proportion of participants with on-treatment virologic breakthrough and relapse
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.

Full Information

First Posted
June 23, 2015
Last Updated
March 16, 2018
Sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02482077
Brief Title
Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients
Official Title
Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 2 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF+RBV 8 wk
Arm Type
Experimental
Arm Description
Participants will receive SOF+RBV for 8 weeks.
Arm Title
SOF+RBV 12 wk
Arm Type
Experimental
Arm Description
Participants will receive SOF+RBV for 12 weeks.
Arm Title
SOF+DCV 8 wk
Arm Type
Experimental
Arm Description
Participants will receive SOF+DCV for 8 weeks.
Arm Title
SOF+DCV 12 wk
Arm Type
Experimental
Arm Description
Participants will receive SOF+DCV for 12 weeks.
Arm Title
LDV/SOF 8 wk
Arm Type
Experimental
Arm Description
Participants will receive LDV/SOF for 8 weeks.
Arm Title
LDV/SOF 12 wk
Arm Type
Experimental
Arm Description
Participants will receive LDV/SOF for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
SOF+RBV
Other Intervention Name(s)
GS-7977, PSI-7977, Sovaldi®, Copegus®
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
SOF+DCV
Other Intervention Name(s)
GS-7977, PSI-7977, Sovaldi®, BMS-790052, Daklinza®
Intervention Description
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
Intervention Type
Drug
Intervention Name(s)
LDV/SOF
Other Intervention Name(s)
GS-7977/GS-5885, Harvoni®
Intervention Description
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
Primary Outcome Measure Information:
Title
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy
Description
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Time Frame
Post treatment Week 12
Title
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Time Frame
Baseline up to Week 24
Secondary Outcome Measure Information:
Title
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
Time Frame
Baseline up to Week 24
Title
HCV RNA levels and change during and after treatment.
Time Frame
Baseline up to Week 24
Title
Proportion of participants with on-treatment virologic breakthrough and relapse
Description
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.
Time Frame
Baseline up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age equal to or greater than 18 years, with chronic genotype 2 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 Use of two effective contraception methods if female of childbearing potential or sexually active male 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George KK Lau, MD
Organizational Affiliation
Humanity and Health GI and Liver Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Humanity and Health GI and Liver Centre
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
00852
Country
China

12. IPD Sharing Statement

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

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