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 genotype 3 infection.
Interventions
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (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
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy | 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 |
| Incidence of adverse events leading to permanent discontinuation of study drug | Baseline up to Week 12 | — |
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 12 | — |
| HCV RNA levels and change during and after treatment | Baseline up to Week 12 | — |
| Treatment adherence | Baseline to Week 12 | To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation) |
| Change in health related quality of life | Baseline to Week 24 | To evaluate the change in health-related quality of life during treatment |
Countries
China
Outcome results
None listed