Chronic Hepatitis C Infection
Conditions
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.
Interventions
DRUGSOF+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).
DRUGSOF+DCV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
DRUGLDV/SOF
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
Sponsors
Beijing 302 Hospital
Humanity and Health Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed