Overview

Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III

Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ascletis Pharmaceuticals Co., Ltd.
Treatments:
Interferon-alpha
Lactams
Peginterferon alfa-2a
Ribavirin
Ritonavir
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 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