HCV
Conditions
Keywords
HCV, Ravidasvir, SVR12
Brief summary
The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients.
Interventions
DRUGRavidasvir
Ravidasvir 200mg tablet administered orally once daily
DRUGDanoprevir
Danoprevir 100mg tablet administered orally twice daily
DRUGRitonavir
Ritonavir 100mg tablet administered orally twice daily
DRUGRibavirin 100 MG
Ribavirin tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(\<75kg = 1000mg and ≥75kg = 1200mg)
DRUGRavidasvir Placebo
Ravidasvir Placebo tablet administered orally once daily
Danoprevir Placebo tablet administered orally twice daily
Ritonavir Placebo tablet administered orally twice daily
DRUGRibavirin Placebo
Ribavirin Placebo tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(\<75kg = 5 tablets and ≥75kg = 6 tablets)
Sponsors
Ascletis Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Infection with Chronic hepatitis C genotype 1confirmed at screening; * Anti-HCV positive； * HCV RNA ≥1 × 10000IU / mL; * Not treated with interferon and / or any other direct-acting antiviral (DAA) drug; * Non-cirrhotic; * Voluntarily sign informed consent.
Exclusion criteria
* HCV genotypes 2 to 7 or undetectable HCV genotype or mixed HCV genotype; * Fibroscan detection result \> 12.9kPa or Histopathological examination result of patients is with cirrhosis; * Past or existing evidence of the presence of non-HCV-induced chronic liver disease; * Previous history of hepatocellular carcinoma, or suspected hepatocellular carcinoma found prior to screening, or suspected abdominal hepatoblastoma at screening or AFP\>100ng/mL; * Anti-HAV (IgM) 、HBsAg 、anti-HEV (IgM) or anti-HIV is positive; * BMI\<18 or≥30 kg/m2; * ANC\<1.5×109/L、PLT\<100×109/L、HB\<110g/L（female）or\<120g/L（male）；INR\>1.5；ALT or AST≥5\*ULN；TBIL≥2\*ULN（DBIL≥ 35%TBIL）；Cr≥1.5\*ULN; * Others as specified in detailed protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants achieving sustained Virologic response 12 weeks after EOT | Post treatment Week 12 | SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy |
| Adverse events leading to permanent discontinuation of study drug | baseline to week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quatitation change of HCV RNA compared to baseline after treatment | Baseline to week 1 | — |
| Percentage of Participants achieving sustained Virologic response 4 weeks after EOT | Post treatment Week 4 | SVR4 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 4 weeks after cessation of therapy |
| Percentage of participants with viral relapse | End of treatment to post-treatment week 24 | Viral relapse was defined as HCV RNA ≥LLOQ during the post treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values. |
| Percentage of participants with viral breakthrough | Baseline to week 12 | Viral breakthrough was defined as HCV RNA ≥LLOQ after having previously had HCV RNA\< LLOQ while receiving treatment, confirmed with 2 consecutive values |
| Percentage of Participants achieving sustained Virologic response 24 weeks after EOT | Post treatment Week 24 | SVR24 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 24 weeks after cessation of therapy |
Countries
China
Outcome results
None listed