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

Chronic HCV Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05395416
• Other study ID #: HEC74647/HEC110114-?/?-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 21, 2021
• Est. completion date: April 22, 2023

Study information

• Verified date: May 2022
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: Lai Wei, Doctor
• Phone: 13601281862
• Email: weelai[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: April 22, 2023
• Est. primary completion date: April 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic HCV Infection
• Hepatitis C
• Infections

Intervention

Drug:
• HEC74647PA+HEC110114
administered orally once daily for 12 weeks
• Placebo
administered orally once daily for 12 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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 Virologic relapse: Confirmed HCV RNA =the lower limit of quantitation (LLOQ) during the posttreatment period having achieved HCV RNA	Up to posttreatment week 24