Chronic HCV Infection
Conditions
Brief summary
The safety, tolerability and antiviral activity of Antaitavir Hasophate in Combination With Yiqibuvir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) infection
Detailed description
Phase II: Exploring the efficacy and safety of different doses of Antaitavir Hasophate combined with fixed-dose Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials. Phase III: Confirmation of the efficacy and safety of Antaitavir Hasophate combined with Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.
Interventions
DRUGHEC74647PA+HEC110114
administered orally once daily for 12 weeks
DRUGPlacebo
administered orally once daily for 12 weeks
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing and able to provide written informed consent; 2. Male or female, age≥18 years; 3. Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg; 4. Serological detection of anti-HCV antibodies was positive at screening; 5. HCV RNA≥1×104 IU/mL at Screening; 6. HCV genotype 1\ 6, mixed genotype or indeterminate assessed at Screening by the Central Laboratory.
Exclusion criteria
1. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage); 2. Chronic liver disease of a non-HCV etiology (Including but not limited to hemochromatosis, Wilson's disease,alfa-1 antitrypsin deficiency); 3. Significant cardiac disease(Including but not limited to myocardial infarction, bradycardia) ; 4. Psychiatric illness or psychological disease or relevant medical history; 5. Solid organ transplantation; 6. Subjects have any other medical disorder that may interfere with subjects treatment, assessment or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained virologic response at 12 weeks after end of treatment (SVR12) | Posttreatment Week 12 | Percentage of subjects with plasma HCV RNA not detected or below the lower limit of quantitation (15 IU/mL) |
| Type and frequencies of Adverse events | Up to posttreatment week 24 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) | Posttreatment Weeks 4 and 24 | SVR4 and SVR24 were defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 4 and 24 weeks after stopping study treatment, respectively |
| Percentage of subjects with virologic failure | Up to posttreatment week 24 | 1. On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) after having previously had HCV RNA \<the lower limit of quantitation (LLOQ) while on treatment), or Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment); 2. Virologic relapse: Confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) during the posttreatment period having achieved HCV RNA \<the lower limit of quantitation (LLOQ) at last on-treatment visit. |
Countries
China
Outcome results
None listed