Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G… (NCT03020082) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III
141 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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\<Fibroscan indicator ≤12.9, liver biopsy need to confirm non-cirrhosis.
* Others as specified in the detailed protocol
Exclusion Criteria:
* Patients with Fibroscan detection value \> 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
What they're measuring
1
Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)