CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Ravidasvir +3 moredrug
Likely dose
Ravidasvir 200 mg orally once daily + Danoprevir 100 mg orally twice daily + Ritonavir 100 mg orally twice daily + Ribavirin 1000/1200 mg/day (based on body weight <75/>≥75 kg)AI-extracted
Key inclusion· 4
  • ✓Chronic HCV infection for ≥6 months with HCV RNA ≥1×10⁴ IU/mL
  • ✓Never received prior HCV treatment with interferon, ribavirin, direct-acting antivirals, or host-targeting antivirals
  • ✓Non-cirrhotic chronic liver disease confirmed by liver biopsy (Metavir <4) within 36 months OR Fibroscan <14.6 kPa; study-related Fibroscan required if no prior imaging within 3 years
  • ✓Willing and able to provide written informed consent
Key exclusion· 9
  • ✕Pregnant or lactating women
  • ✕History or presence of decompensated liver disease (ascites, hepatic encephalopathy, HCC, bleeding esophageal varices)
  • ✕Non-hepatitis C chronic liver disease including autoimmune hepatitis, α-1-antitrypsin deficiency, hemochromatosis, Wilson's disease, drug/toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, porphyria cutanea tarda
  • ✕Positive hepatitis B surface antigen or HIV antibody at screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03020095
NCT03020095Phase 2Completed
CompareCT.gov

Phase 2 Study To Investigate the Efficacy, Safety And Pharmacokinetics Of Ravidasvir In Combination With Ritonavir-boosted Danoprevir And Ribavirin In Treatment-naive Non-cirrhotic Taiwanese Patients Who Have Chronic Hepatitis C Genotype 1

Ascletis Pharmaceuticals Co., Ltd.·interventional·Posted Jan 13, 2017·Updated Oct 22, 2020

In Brief

A Phase 2 clinical trial evaluating Ravidasvir, Danoprevir, and 2 other interventions for Chronic Hepatitis C. Completed, enrolled 38 participants.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 13, 2017
Enrollment StartAug 1, 2015
Primary CompletionAug 1, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.5 years ago

Interventions

Ravidasvirdrug

Ravidasvir 200mg tablet administered orally once daily

Danoprevirdrug

Danoprevir 100mg tablet administered orally twice daily

Ritonavirdrug

Ritonavir 100mg tablet administered orally twice daily

Ribavirindrug

Ribavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally