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CompletedNCT05395416Updated May 14, 2025

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

A Phase 2/3 interventional study of HEC74647PA+HEC110114 and Placebo in Chronic HCV Infection, sponsored by Sunshine Lake Pharma Co., Ltd.. Completed at 36 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Sunshine Lake Pharma Co., Ltd. · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2021, registered May 2022).
Phase
Phase 2/3
Study type
Interventional
Enrollment
514
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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

Read the 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.

02

Conditions studied

  • Chronic HCV Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 514 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Sunshine Lake Pharma Co., Ltd. is the lead sponsor of 82 studies on the registry; 13 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
514 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugHEC74647PA+HEC110114

    administered orally once daily for 12 weeks

    Also known as: Antaitavir Hasophate+Yiqibuvir

  • DrugPlacebo

    administered orally once daily for 12 weeks

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Posttreatment Week 12

  2. Type and frequencies of Adverse events

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: Up to posttreatment week 24

Secondary outcomes

  1. 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

    Time frame: Posttreatment Weeks 4 and 24

  2. Percentage of subjects with virologic failure

    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.

    Time frame: Up to posttreatment week 24

07

Study locations

36 sites
  • The First Affiliated Hospital of Bengbu Medical College
    Bengbu, Anhui, China
  • The Second Hospital of Anhui Medical University
    Hefei, Anhui, China
  • Anhui Provincial Hospital
    Hefei, Anwei, China
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
  • Beijing Tsinghua Changgung Hospital
    Beijing, Beijing 102200, China
  • The 900th Hospital of the Joint Logistics Support Force Hospital
    Fuzhou, Fujian, China
  • Foshan First People's Hospital
    Foshan, Guangdong, China
  • Guangzhou Eighth People's Hospital
    Guangzhou, Guangdong, China
  • Nanfang Hospital of Southern Medical University
    Guangzhou, Guangdong, China
  • Hainan Provincial People's Hospital
    Haikou, Hainan, China
  • The Third Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
  • Wuhan University People's Hospital
    Wuhan, Hebei, China
  • The Fourth Affiliated Hospital of Harbin Medical University
    Haerbin, Heilongjiang, China
  • Luoyang Central Hospital
    Luoyang, Henan, China
  • The First Affiliated Hospital of Xinxiang Medical College
    Xinxiang, Henan, China
  • Henan Infectious Diseases Hospital
    Zhengzhou, Henan, China
  • Henan Provincial People's Hospital
    Zhengzhou, Henan, China
  • Zhengzhou People's Hospital
    Zhengzhou, Henan, China
  • Hunan Provincial People's Hospital
    Changsha, Hunan, China
  • Xiangya Hospital Central South University
    Changsha, Hunan, China
  • The First Affiliated Hospital of South China
    Hengyang, Hunan, China
  • The First People's Hospital of Lianyungang
    Lianyungang, Jiangsu, China
  • Jiangsu Provincial Hospital
    Nanjing, Jiangsu, China
  • Nanjing Second Hospital
    Nanjing, Jiangsu, China
  • Wuxi No.5 People's Hospital
    Wuxi, Jiangsu, China
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu, China
  • Zhenjiang Third People's Hospital
    Zhenjiang, Jiangsu, China
  • The First Affiliated Hospital of Nanchang University
    Nanyang, Jiangxi, China
  • The First Hospital of Jilin University
    Changchun, Jilin, China
  • Tonghua Central Hospital
    Tonghua, Jilin, China
  • Yanbian University Hospital
    Yanbian, Jilin, China
  • The Sixth People's Hospital Of Shenyang
    Shenyang, Liaoning, China
  • Qingdao Municipal Hospital
    Qingdao, Shandong, China
  • Huashan Hospital of the Fudan University
    Shanghai, Shanghai, China
  • Tianjin Third Central Hospital
    Tianjin, Tianjin, China
  • Beijing You'an Hospital,Capital Medical University
    Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05395416
Lead sponsor
Sunshine Lake Pharma Co., Ltd.
Responsible party
Sponsor
First posted
May 27, 2022
Start date
Jun 21, 2021
Primary completion
Apr 11, 2023
Completion
Apr 11, 2023
Last update
May 14, 2025

Study contacts

Lai Wei, Doctor
study chair · Beijing Tsinghua Changgeng Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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