Clinical trial NCT03362814: Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Virus Genotype1 Infected Subjects.
Official title: A Phase2/3, Multi-center, Randomized, Double-blind, Placebo-parallel Controlled Study to Investigate the Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Genotype 1 Infected Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HCV
Keywords: HCV
Ravidasvir
SVR12
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-12-05
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants achieving sustained Virologic response 12 weeks after EOT
timeFrame: Post treatment Week 12
measure: Adverse events leading to permanent discontinuation of study drug
timeFrame: baseline to week 12
Secondary outcomes:
measure: Percentage of Participants achieving sustained Virologic response 4 weeks after EOT
timeFrame: Post treatment Week 4
measure: Percentage of Participants achieving sustained Virologic response 24 weeks after EOT
timeFrame: Post treatment Week 24
measure: Quatitation change of HCV RNA compared to baseline after treatment
timeFrame: Baseline to week 1
measure: Percentage of participants with viral breakthrough
timeFrame: Baseline to week 12
measure: Percentage of participants with viral relapse
timeFrame: End of treatment to post-treatment week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's hospital
state: Beijing
Study officials:
affiliation: Ascletis Pharmaceuticals Co., Ltd.
name: Yahong Chen, Master
role: STUDY_DIRECTOR
References: