CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Danoprevir +3 moredrug
Likely dose
Danoprevir 100 mg orally twice daily, ritonavir 100 mg orally twice daily, peginterferon alfa-2a 180 mcg subcutaneously weekly, ribavirin 1000/1200 mg/day (weight-based)AI-extracted
Key inclusion· 6
  • ✓Chronic HCV infection for ≥6 months duration
  • ✓Positive HCV antibody
  • ✓Serum HCV RNA ≥1 × 10^4 IU/mL
  • ✓Hepatitis C virus genotype 1
Key exclusion· 4
  • ✕Fibroscan >12.9 kPa or histologic evidence of cirrhosis
  • ✕Non-hepatitis C chronic liver disease (autoimmune hepatitis, α-1-antitrypsin deficiency, hemochromatosis, Wilson's disease, drug/toxin-induced, alcohol-related, primary biliary cirrhosis, sclerosing cholangitis, porphyria cutanea tarda)
  • ✕History of hepatocellular carcinoma or suspected HCC on imaging or AFP >50 ng/mL
  • ✕Positive hepatitis A antibody, hepatitis B surface antigen, syphilis antibody, or HIV antibody

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

Search/NCT03020004
NCT03020004Phase 2Completed
CompareCT.gov

A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1

Ascletis Pharmaceuticals Co., Ltd.·interventional·Posted Jan 13, 2017·Updated Jul 26, 2018

In Brief

A Phase 2 clinical trial evaluating Danoprevir, Ritonavir, and 2 other interventions for Chronic Hepatitis C. Completed, enrolled 70 participants.

Detailed Summary

The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 13, 2017
Enrollment StartJan 1, 2016
Primary CompletionNov 1, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.5 years ago

Interventions

Danoprevirdrug

Danoprevir (DNV) 100mg tablet administered orally twice daily

Ritonavirdrug

Ritonavir 100mg tablet administered orally twice daily

peginterferon alfa-2adrug

PegIFN subcutaneous injection at 180 mcg weekly

Ribavirin (RBV)drug

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