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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03362814
Other study ID # ASC-ASC16-II/III-CTP-1-01
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 1, 2017
Est. completion date April 24, 2019

Study information

Verified date November 2017
Source Ascletis Pharmaceuticals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 425
Est. completion date April 24, 2019
Est. primary completion date December 12, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ravidasvir
Ravidasvir 200mg tablet administered orally once daily
Danoprevir
Danoprevir 100mg tablet administered orally twice daily
Ritonavir
Ritonavir 100mg tablet administered orally twice daily
Ribavirin 100 MG
Ribavirin tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 1000mg and =75kg = 1200mg)
Ravidasvir Placebo
Ravidasvir Placebo tablet administered orally once daily
Danoprevir Placebo
Danoprevir Placebo tablet administered orally twice daily
Ritonavir Placebo
Ritonavir Placebo tablet administered orally twice daily
Ribavirin 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)

Locations

Country Name City State
China Peking University People's hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants achieving sustained Virologic response 12 weeks after EOT SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy Post treatment Week 12
Primary Adverse events leading to permanent discontinuation of study drug baseline to week 12
Secondary Percentage of Participants achieving sustained Virologic response 4 weeks after EOT SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks after cessation of therapy Post treatment Week 4
Secondary Percentage of Participants achieving sustained Virologic response 24 weeks after EOT SVR24 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 24 weeks after cessation of therapy Post treatment Week 24
Secondary Quatitation change of HCV RNA compared to baseline after treatment Baseline to week 1
Secondary Percentage of participants with viral breakthrough Viral breakthrough was defined as HCV RNA =LLOQ after having previously had HCV RNA< LLOQ while receiving treatment, confirmed with 2 consecutive values Baseline to week 12
Secondary Percentage of participants with viral relapse 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. End of treatment to post-treatment week 24
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