Phase 3
Completed N=141
Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT03020082 ↗
Enrolled (actual)
141
Serious AEs
3.6%
Results posted
Mar 2021
Primary outcomePrimary: Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 136 Participants
◆ Published Evidence
Emerging
12citations · ~2 / year
Efficacy and Safety of 12-week Interferon-based Danoprevir Regimen in Patients with Genotype 1 Chronic Hepatitis C.
Summary
The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.
Linked Publications
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Efficacy and Safety of 12-week Interferon-based Danoprevir Regimen in Patients with Genotype 1 Chronic Hepatitis C.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
136 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent
- Chronic HCV infection (≥ 6 months)
- Serum HCV RNA of ≥ 1 × 104 IU/mL are documented
- Hepatitis C virus GT1
- Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
- Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa during screening period, or liver biopsy determined 1 year before recruiting (Metavir score ˂ 3);(2) during screening period 9.6 12.9 kPa, or histologic examination for liver cirrhosis patients
- Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)
- History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients before or during screening , or imaging studies found suspicious nodules, or AFP > 50 ng/mL
- Positive hepatitis A antibody，positive hepatitis B surface antigen，HIV antibody
- Presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself.
- Patients with obvious cardiovascular dysfunction
- Pregnant or nursing female, nor unwilling to take reliable contraception
- Others as specified in the detailed protocol
Data sourced from ClinicalTrials.gov (NCT03020082) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.