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

Phase 4

Completed

• Conditions: Chronic Hepatitis C Infection
• Interventions: Drug: LDV/SOF; Drug: SOF+RBV; Drug: SOF+DCV

• Registration Number: NCT02482077
• Lead Sponsor: Humanity and Health Research Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-25
• Primary Completion: 2017-12-31
• Status Verified: 2018-03
• Study Completion: 2018-03-15
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDV/SOF 12 wk	LDV/SOF	Participants will receive LDV/SOF for 12 weeks.
SOF+RBV 8 wk	SOF+RBV	Participants will receive SOF+RBV for 8 weeks.
SOF+RBV 12 wk	SOF+RBV	Participants will receive SOF+RBV for 12 weeks.
SOF+DCV 8 wk	SOF+DCV	Participants will receive SOF+DCV for 8 weeks.
SOF+DCV 12 wk	SOF+DCV	Participants will receive SOF+DCV for 12 weeks.
LDV/SOF 8 wk	LDV/SOF	Participants will receive LDV/SOF for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital; 🇨🇳 Beijing, Beijing, China

Humanity and Health GI and Liver Centre; 🇨🇳 Hong Kong, Hong Kong, China