Chronic Hepatitis C
Conditions
Keywords
Danoprevir, non-cirrhotic, Chinese HCV G1, SVR12
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.
Interventions
DRUGRBV
RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
DRUGDanoprevir
Danoprevir (DNV)administered orally 100mg BID for 12 weeks;
DRUGRitonavir
Ritonavir administered orally 100mg BID for 12 weeks;
DRUGpeginterferon alfa-2a
PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;
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) * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 12 weeks |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Danoprevir, Ritonavir, Peg-IFN,RBV Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.
Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks;
Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks;
peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;
RBV: RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks. | 141 |
| Total | 141 |
Baseline characteristics
| Characteristic | Danoprevir, Ritonavir, Peg-IFN,RBV |
|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 12.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 141 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 | 70 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 141 |
| other Total, other adverse events | 76 / 141 |
| serious Total, serious adverse events | 5 / 141 |
Outcome results
Primary
Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Danoprevir, Ritonavir, Peg-IFN,RBV | Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 136 Participants |