Chronic Hepatitis C Infection
Conditions
Brief summary
There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.
Interventions
DRUGSOF+DCV+SMV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
Sponsors
University of Maryland
Emory University
Beijing 302 Hospital
Humanity and Health Research Centre
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. HCV RNA positive \>2000 IU/ml or NAT POC positive 2. Genotype 1b 3. CP score ≤6
Exclusion criteria
1. Pregnant or nursing female or male with pregnant female partner 2. Hematologic or biochemical parameters at Screening outside the protocol- specified requirements 3. Active or recent history (≤ 1 year) of drug or alcohol abuse 4. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers) 5. History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with plasma HCV viral load below the lower limit of quantification for 12 weeks after treatment completion (SVR12) | Post treatment Week 12 | SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after last dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kinetics of circulating HCV RNA during treatment and after treatment discontinuation | Baseline up to Week 24 | — |
| Frequency and severity of adverse events | Baseline up to Week 24 | — |
| Proportion of participants with unquantifiable HCV viral load at specified time points 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 up to 24 weeks. |
Countries
Hong Kong
Outcome results
None listed