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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic HCV Infection
• Intervention / Treatment: Drug: HEC74647PA+HEC110114; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 514
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing You'an Hospital,Capital Medical University
  • Anhui
    • Bengbu, Anhui, China
      • The First Affiliated Hospital of Bengbu Medical College
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University
  • Anwei
    • Hefei, Anwei, China
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
    • Beijing, Beijing, China, 102200
      • Beijing Tsinghua Changgung Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • The 900th Hospital of the Joint Logistics Support Force Hospital
  • Guangdong
    • Foshan, Guangdong, China
      • Foshan First People's Hospital
    • Guangzhou, Guangdong, China
      • Nanfang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • Guangzhou Eighth People's Hospital
  • Hainan
    • Haikou, Hainan, China
      • Hainan Provincial People's Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • The Third Hospital of Hebei Medical University
    • Wuhan, Hebei, China
      • Wuhan University People's Hospital
  • Heilongjiang
    • Haerbin, Heilongjiang, China
      • The Fourth Affiliated Hospital of Harbin Medical University
  • Henan
    • Luoyang, Henan, China
      • Luoyang Central Hospital
    • Xinxiang, Henan, China
      • The First Affiliated Hospital of Xinxiang Medical College
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China
      • Henan Infectious Diseases Hospital
    • Zhengzhou, Henan, China
      • Zhengzhou People's Hospital
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital Central South University
    • Changsha, Hunan, China
      • Hunan Provincial People's Hospital
    • Hengyang, Hunan, China
      • The First Affiliated Hospital of South China
  • Jiangsu
    • Lianyungang, Jiangsu, China
      • The First People's Hospital of Lianyungang
    • Nanjing, Jiangsu, China
      • Jiangsu Provincial Hospital
    • Nanjing, Jiangsu, China
      • Nanjing Second Hospital
    • Wuxi, Jiangsu, China
      • Wuxi No.5 People's Hospital
    • Xuzhou, Jiangsu, China
      • The Affiliated Hospital of Xuzhou Medical University
    • Zhenjiang, Jiangsu, China
      • Zhenjiang Third People's Hospital
  • Jiangxi
    • Nanyang, Jiangxi, China
      • The First Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
    • Tonghua, Jilin, China
      • Tonghua Central Hospital
    • Yanbian, Jilin, China
      • Yanbian University Hospital
  • Liaoning
    • Shenyang, Liaoning, China
      • The Sixth People's Hospital of Shenyang
  • Shandong
    • Qingdao, Shandong, China
      • Qingdao Municipal Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Huashan Hospital of the Fudan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Third Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.
• Investigators: Study Chair: Lai Wei, Doctor, Beijing Tsinghua Changgeng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): April 11, 2023

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Infections; Hepatitis C
• Other Study ID Numbers: HEC74647/HEC110114-Ⅱ/Ⅲ-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No