Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase Ⅱ/Ⅲ Study to Evaluate Efficacy and Safety of Antaitavir Hasophate Capsules in Combination With Yiqibuvir Tablets in Adult Subject With Chronic HCV Infection

Conditions
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Chronic HCV Infection

Intervention / Treatment
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* Drug: HEC74647PA+HEC110114
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide written informed consent; Male or female, age≥18 years; Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg; Serological detection of anti-HCV antibodies was positive at screening; HCV RNA≥1×104 IU/mL at Screening; HCV genotype 1 6, mixed genotype or indeterminate assessed at Screening by the Central Laboratory. Exclusion Criteria: Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage); Chronic liver disease of a non-HCV etiology (Including but not limited to hemochromatosis, Wilson's disease,alfa-1 antitrypsin deficiency); Significant cardiac disease(Including but not limited to myocardial infarction, bradycardia) ; Psychiatric illness or psychological disease or relevant medical history; Solid organ transplantation; Subjects have any other medical disorder that may interfere with subjects treatment, assessment or compliance with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEC74647PA+HEC110114 100 mg/200 mg<br>Phase II: HCV GT 1-6 participants were medicated with HEC74647PA Capsules 100 mg or200 mg once daily and HEC110114 tablets 600 mg once daily | Drug: HEC74647PA+HEC110114<br>* administered orally once daily for 12 weeks<br>* Other names: Antaitavir Hasophate+Yiqibuvir;|
| Experimental: HEC74647PA+HEC110114<br>Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Capsules 100 mg /200 mg once daily and HEC110114 tablets 600 mg once daily | Drug: HEC74647PA+HEC110114<br>* administered orally once daily for 12 weeks<br>* Other names: Antaitavir Hasophate+Yiqibuvir;|
| Placebo Comparator: Placebo<br>Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Placebo Capsules once daily and HEC110114 Placebo tablets once daily | Drug: Placebo<br>* administered orally once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virologic response at 12 weeks after end of treatment (SVR12) | Percentage of subjects with plasma HCV RNA not detected or below the lower limit of quantitation (15 IU/mL) | Posttreatment Week 12 | 
| Type and frequencies of Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Up to posttreatment week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) at 4 and 24 weeks after stopping study treatment, respectively | Posttreatment Weeks 4 and 24 | 
| Percentage of subjects with virologic failure | 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); 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. | Up to posttreatment week 24 |