Clinical trial NCT03020082: Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III
Official title: A Multi-centered, Open Label, Phase III Study on Efficacy, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Danoprevir
non-cirrhotic
Chinese HCV G1
SVR12
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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\<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

Primary outcomes:
measure: Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ascletis Pharmaceuticals Co., Ltd.
name: Huoling Tang, PhD
role: STUDY_DIRECTOR
References:
citation: Wei L, Shang J, Ma Y, Xu X, Huang Y, Guan Y, Duan Z, Zhang W, Gao Z, Zhang M, Li J, Jia J, Yang Y, Wen X, Wang M, Jia Z, Ning B, Chen Y, Qi Y, Du J, Jiang J, Tong L, Xie Y, Wu JJ. Efficacy and Safety of 12-week Interferon-based Danoprevir Regimen in Patients with Genotype 1 Chronic Hepatitis C. J Clin Transl Hepatol. 2019 Sep 28;7(3):221-225. doi: 10.14218/JCTH.2019.00018. Epub 2019 Jul 22.