Chronic Hepatitis C
Conditions
Keywords
Ravidasvir, HCV GT1, SVR12, Danoprevir/r
Brief summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.
Interventions
DRUGRavidasvir
Ravidasvir 200mg tablet administered orally once daily
DRUGDanoprevir
Danoprevir 100mg tablet administered orally twice daily
DRUGRitonavir
Ritonavir 100mg tablet administered orally twice daily
DRUGRibavirin
Ribavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally
Sponsors
Ascletis Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide written informed consent * Chronic HCV infection (≥6 months) , HCV RNA ≥ 1 × 104 IU/mL * Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV * Chronic liver disease consistent with CHC infection without cirrhosis as determined by biopsy obtained within the past calendar 36 months using one of 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 3 years will have a study related Fibroscan performed in order to confirm the diagnosis. Liver biopsy will be performed by investigator's judgement * All male patients with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin * Others as specified in detailed protocol.
Exclusion criteria
* Pregnant or lactating women. * History or presence of decompensated liver disease (history of ascites, hepatic encephalopathy, HCC, or bleeding esophageal varices) * 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 * Positive hepatitis B surface antigen or HIV antibody at screening * History or presence of liver cirrhosis * History of severe psychiatric disease, including psychosis and/or depression, who is not able to participate or able to give written informed consent and to comply with the study restrictions * History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin) * History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia's requiring ongoing treatment, unstable angina or other unstable, uncontrolled or significant cardiovascular disease within 6 months). Patients with stable coronary artery disease (e.g., 6 months after by-pass surgery, angioplasty with or without stent placement, etc.) as confirmed by a cardiologist will be permitted. In addition, patients with documented or presumed unstable coronary artery disease, cardiovascular disease, or cerebrovascular disease should not be enrolled. * Any patient with an increased risk for anemia (e.g., thalassemia, sickle cell anemia, or spherocytosis) or for whom anemia would be medically problematic * History of pre-existing renal disease, patients with a history of nephrolithiasis will be allowed * Others as specified in detailed protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment | 12 weeks | SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ravidasvir,Danoprevir/r,RBV Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.
Ravidasvir: Ravidasvir 200mg tablet administered orally once daily
Danoprevir: Danoprevir 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Ravidasvir,Danoprevir/r,RBV |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 12.76 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 38 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 |
| Region of Enrollment Taiwan | 38 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 14 / 38 |
| serious Total, serious adverse events | 0 / 38 |
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: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ravidasvir,Danoprevir/r,RBV | Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment | 38 Participants |