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

Sponsor

Humanity and Health Research Centre (Other)

Overall Status

Completed

CT.gov ID

NCT02482077

Collaborator

Beijing 302 Hospital (Other)

112

Enrollment

Locations

Arms

38.4

Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Infection	Drug: SOF+RBV Drug: SOF+DCV Drug: LDV/SOF	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Mar 15, 2018

Arms and Interventions

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: GS-7977 PSI-7977 Sovaldi® Copegus®
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: GS-7977 PSI-7977 Sovaldi® Copegus®
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: GS-7977 PSI-7977 Sovaldi® 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: GS-7977 PSI-7977 Sovaldi® 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: GS-7977/GS-5885 Harvoni®
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: GS-7977/GS-5885 Harvoni®

Outcome Measures

Primary Outcome Measures

Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy [Post treatment Week 12]
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) [Baseline up to Week 24]

Secondary Outcome Measures

Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment [Baseline up to Week 24]
HCV RNA levels and change during and after treatment. [Baseline up to Week 24]
Proportion of participants with on-treatment virologic breakthrough and relapse [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital	Beijing	Beijing	China	100039
2	Humanity and Health GI and Liver Centre	Hong Kong	Hong Kong	China	00852