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

Sunshine Lake Pharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic HCV Infection

Treatments: Drug: Placebo; Drug: HEC74647PA+HEC110114

Study type: Interventional

Funder types: Industry

Identifiers

NCT05395416

HEC74647/HEC110114-Ⅱ/Ⅲ-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 514 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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514 participants in 3 patient groups, including a placebo group

HEC74647PA+HEC110114 100 mg/200 mg

Experimental group

Description:

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

Treatment:

Drug: HEC74647PA+HEC110114

HEC74647PA+HEC110114

Experimental group

Description:

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

Treatment:

Drug: HEC74647PA+HEC110114

Placebo

Placebo Comparator group

Description:

Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Placebo Capsules once daily and HEC110114 Placebo tablets once daily

Treatment:

Drug: Placebo