Phase 2 Completed N=70 Treatment

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

Chronic Hepatitis C

Source: ClinicalTrials.gov NCT03020004 ↗

Enrolled (actual)

Serious AEs

1.4%

Results posted

Feb 2018

Primary outcomePrimary: Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment — 66 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment	66	—

Eligibility Criteria

Inclusion Criteria

Willing and able to provide written informed consent
Chronic HCV infection (≥ 6 months) ;
Positive HCV antibody
Serum HCV RNA of ≥ 1 × 104 IU/mL
Hepatitis C virus GT1
Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
The liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂ 4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not obtained a liver biopsy or Fibroscan in the last 1 years will have a study related Fibroscan performed in order to confirm the diagnosis
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, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy
Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP > 50 ng/mL
Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody or HIV antibody at screening
Others as specified in the detailed protocol

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Data sourced from ClinicalTrials.gov (NCT03020004). 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.