Chronic Hepatitis C
Conditions
Keywords
Danoprevir, SVR12, Chinese HCV G1, non-cirrhotic
Brief 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.
Interventions
DRUGDanoprevir
Danoprevir (DNV) 100mg tablet administered orally twice daily
DRUGRitonavir
Ritonavir 100mg tablet administered orally twice daily
DRUGpeginterferon alfa-2a
PegIFN subcutaneous injection at 180 mcg weekly
DRUGRibavirin (RBV)
Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)
Sponsors
Ascletis Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment | 24 weeks | SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Danoprevir,Ritonavir, Peg-IFN,RBV Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) for 12 weeks.
Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly
Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | Danoprevir,Ritonavir, Peg-IFN,RBV |
|---|---|
| Age, Continuous | 41.2 years STANDARD_DEVIATION 12.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 70 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 70 / 70 |
| serious Total, serious adverse events | 1 / 70 |
Outcome results
Primary
Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Danoprevir,Ritonavir, Peg-IFN,RBV | Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment | 66 Participants |