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

Primary Purpose

Chronic HCV Infection

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HEC74647PA+HEC110114
Placebo
Sponsored by
Sunshine Lake Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic HCV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • The Second Hospital of Anhui Medical UniversityRecruiting
  • Anhui Provincial HospitalRecruiting
  • Peking University People's HospitalRecruiting
  • Beijing Tsinghua Changgung HospitalRecruiting
  • The 900th Hospital of the Joint Logistics Support Force HospitalRecruiting
  • Foshan First People's HospitalRecruiting
  • Guangzhou Eighth People's HospitalRecruiting
  • Nanfang Hospital of Southern Medical UniversityRecruiting
  • Hainan Provincial People's HospitalRecruiting
  • The Third Hospital of Hebei Medical UniversityRecruiting
  • Wuhan University People's HospitalRecruiting
  • The Fourth Affiliated Hospital of Harbin Medical UniversityRecruiting
  • Luoyang Central HospitalRecruiting
  • The First Affiliated Hospital of Xinxiang Medical CollegeRecruiting
  • Henan Infectious Diseases HospitalRecruiting
  • Henan Provincial People's HospitalRecruiting
  • Zhengzhou People's HospitalRecruiting
  • Hunan Provincial People's HospitalRecruiting
  • Xiangya Hospital Central South UniversityRecruiting
  • The First Affiliated Hospital of South ChinaRecruiting
  • The First People's Hospital of LianyungangRecruiting
  • Jiangsu Provincial HospitalRecruiting
  • Nanjing Second HospitalRecruiting
  • Wuxi No.5 People's HospitalRecruiting
  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
  • Zhenjiang Third People's HospitalRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Tonghua Central HospitalRecruiting
  • Yanbian University HospitalRecruiting
  • The Sixth People's Hospital Of ShenyangRecruiting
  • Qingdao Municipal HospitalRecruiting
  • Huashan Hospital of the Fudan UniversityRecruiting
  • Tianjin Third Central HospitalRecruiting
  • Beijing You'an Hospital,Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

HEC74647PA+HEC110114 100 mg/200 mg

HEC74647PA+HEC110114

Placebo

Arm 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

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

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

Outcomes

Primary Outcome Measures

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)
Type and frequencies of Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

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
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.

Full Information

First Posted
May 20, 2022
Last Updated
April 11, 2023
Sponsor
Sunshine Lake Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05395416
Brief Title
Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
April 22, 2023 (Anticipated)
Study Completion Date
April 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic HCV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HEC74647PA+HEC110114 100 mg/200 mg
Arm Type
Experimental
Arm 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
Arm Title
HEC74647PA+HEC110114
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Placebo Capsules once daily and HEC110114 Placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
HEC74647PA+HEC110114
Other Intervention Name(s)
Antaitavir Hasophate+Yiqibuvir
Intervention Description
administered orally once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
administered orally once daily for 12 weeks
Primary Outcome Measure Information:
Title
Sustained virologic response at 12 weeks after end of treatment (SVR12)
Description
Percentage of subjects with plasma HCV RNA not detected or below the lower limit of quantitation (15 IU/mL)
Time Frame
Posttreatment Week 12
Title
Type and frequencies of Adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
Up to posttreatment week 24
Secondary Outcome Measure Information:
Title
Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
Description
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
Title
Percentage of subjects with virologic failure
Description
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.
Time Frame
Up to posttreatment week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lai Wei, Doctor
Phone
13601281862
Email
weelai@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lai Wei, Doctor
Organizational Affiliation
Beijing Tsinghua Changgeng Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chuanmiao liu
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
guizhou zou
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anwei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lei li
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HuiYing Rao, doctor
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lai Wei, Doctor
Facility Name
The 900th Hospital of the Joint Logistics Support Force Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dongliang li
Facility Name
Foshan First People's Hospital
City
Foshan
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
honglian bai
Facility Name
Guangzhou Eighth People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yujuan guan
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jinlin hou
Facility Name
Hainan Provincial People's Hospital
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
feng lin
Facility Name
The Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caiyan Zhao
Facility Name
Wuhan University People's Hospital
City
Wuhan
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zuojiong gong
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Haerbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Yu
Facility Name
Luoyang Central Hospital
City
Luoyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
guoqiang zhang
Facility Name
The First Affiliated Hospital of Xinxiang Medical College
City
Xinxiang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
daokun yang
Facility Name
Henan Infectious Diseases Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gunagming li
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jia shang
Facility Name
Zhengzhou People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yingjie ma
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zheng zhang
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jun quan
Facility Name
The First Affiliated Hospital of South China
City
Hengyang
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhongtian peng
Facility Name
The First People's Hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wenhai zhao
Facility Name
Jiangsu Provincial Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jun li
Facility Name
Nanjing Second Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiabao chang
Facility Name
Wuxi No.5 People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tong sun
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xuebing yan
Facility Name
Zhenjiang Third People's Hospital
City
Zhenjiang
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
youwen tan
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanyang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaoping wu
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
junqi niu
Facility Name
Tonghua Central Hospital
City
Tonghua
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yifei wang
Facility Name
Yanbian University Hospital
City
Yanbian
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hongxin piao
Facility Name
The Sixth People's Hospital Of Shenyang
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bojun li
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yongning xin
Facility Name
Huashan Hospital of the Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiming zhang
Facility Name
Tianjin Third Central Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Han
Facility Name
Beijing You'an Hospital,Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SuJun Zheng

12. IPD Sharing Statement

Learn more about this trial

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

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