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

Last updated: May 12, 2025
Sponsor: Sunshine Lake Pharma Co., Ltd.
Overall Status: Completed

Phase

2/3

Condition

Hepatitis

Hepatitis C; Chronic

Liver Disorders

Treatment

HEC74647PA+HEC110114

Placebo

Clinical Study ID

NCT05395416
HEC74647/HEC110114-Ⅱ/Ⅲ-01
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 theCentral Laboratory.

Exclusion

Exclusion Criteria:

  1. Clinical hepatic decompensation (i.e., ascites, encephalopathy or varicealhemorrhage);

  2. Chronic liver disease of a non-HCV etiology (Including but not limited tohemochromatosis, 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 Design

Total Participants: 514
Treatment Group(s): 2
Primary Treatment: HEC74647PA+HEC110114
Phase: 2/3
Study Start date:
June 21, 2021
Estimated Completion Date:
April 11, 2023

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui
    China

    Site Not Available

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • Anhui Provincial Hospital

    Hefei, Anwei
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing 102200
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • The 900th Hospital of the Joint Logistics Support Force Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Foshan First People's Hospital

    Foshan, Guangdong
    China

    Site Not Available

  • Guangzhou Eighth People's Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Hainan Provincial People's Hospital

    Haikou, Hainan
    China

    Site Not Available

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • Wuhan University People's Hospital

    Wuhan, Hebei
    China

    Site Not Available

  • The Fourth Affiliated Hospital of Harbin Medical University

    Haerbin, Heilongjiang
    China

    Site Not Available

  • Luoyang Central Hospital

    Luoyang, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan
    China

    Site Not Available

  • Henan Infectious Diseases Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Zhengzhou People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Hunan Provincial People's Hospital

    Changsha, Hunan
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, Hunan
    China

    Site Not Available

  • The First Affiliated Hospital of South China

    Hengyang, Hunan
    China

    Site Not Available

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu
    China

    Site Not Available

  • Jiangsu Provincial Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Nanjing Second Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Wuxi No.5 People's Hospital

    Wuxi, Jiangsu
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Site Not Available

  • Zhenjiang Third People's Hospital

    Zhenjiang, Jiangsu
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanyang, Jiangxi
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • Tonghua Central Hospital

    Tonghua, Jilin
    China

    Site Not Available

  • Yanbian University Hospital

    Yanbian, Jilin
    China

    Site Not Available

  • The Sixth People's Hospital Of Shenyang

    Shenyang, Liaoning
    China

    Site Not Available

  • Qingdao Municipal Hospital

    Qingdao, Shandong
    China

    Site Not Available

  • Huashan Hospital of the Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

  • Tianjin Third Central Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Beijing You'an Hospital,Capital Medical University

    Beijing,
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.