Phase 3 Study of Yimitasvir Phosphate Capsules

Chronic HCV Infection Clinical Trial

Official title:

A Multicenter, Single-arm, Open-label Study to Investigate the Efficacy and Safety of Yimitasvir Phosphate (DAG181)/Sofosbuvir(SOF) Combination for 12 Weeks in Subjects With Chronic Genotype 1 HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487107
• Other study ID #: PCD-DDAG181PA-16-007
• Status: Completed
• Phase: Phase 3
• Start date: April 17, 2018
• Est. completion date: June 25, 2019

Study information

• Verified date: March 2020
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The safety, tolerability and antiviral activity of DAG181/SOF in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1 infection.

Description:

A phase III, multicenter, single-arm, open-label study to assess the safety, tolerability and antiviral activity of DAG181/SOF combination for 12 weeks in adult subjects with chronic genotype 1 HCV infection.

Approximately 360 HCV genotype 1 subjects without cirrhosis will be enrolled, treatment-experienced subjects are ≤20%. All subjects will receive DAG181 100 mg/ SOF 400 mg once daily for 12 weeks，with subsequent observation for 24 weeks after cessation of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: June 25, 2019
• Est. primary completion date: March 28, 2019
• 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. A female subject is eligible to enter the study if it is confirmed that she is:

1. Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal-women > 50 years of age with cessation (for=12 months) of previously occurring menses), or

2. Of childbearing potential (Women=50 years of age with amenorrhea will be considered to be of childbearing potential). These women must have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline before first dose of study drugs, and must use specific contraceptive methods from screening until 90 days after last dose of study drugs, such as complete abstinence from intercourse, vaginal ring, cervical cap or contraceptive diaphragm, IUD, etc.

4. All male subjects must agree to consistently and correctly use specific contraceptive methods with their female partner from screening until 90 days after last dose of study drugs(except for surgical sterilization), such as complete abstinence from intercourse, condom, and their female partner use contraceptives , vaginal ring , cervical cap or contraceptive diaphragm, IUD, etc;

5. Male subjects must agree to refrain from sperm donation from the date of screening until 90 days after the last dose of study drugs;

6. Confirmation of chronic HCV infection documented by either:

1. A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or

2. A liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection.

7. Serological detection of anti-HCV antibodies was positive at screening;

8. HCV RNA=1×104 IU/mL at Screening;

9. HCV genotype 1a, 1b, or mixed 1a/1b at screening as determined by the Central Laboratory;

10. Classification as treatment naive or treatment experienced;

11. Absence of cirrhosis.

Exclusion Criteria:

1. Investigator assessed subjects have other clinically significant abnormalities (other than HCV), such as uncontrollable heart disease, respiratory, gastrointestinal, blood, nervous or other medical disorders, which may interfere with treatment, assessment, or compliance with the protocol;

2. Laboratory results outside of acceptable ranges at Screening;

3. HBsAg serology test results were positive at Screening;

4. HIV antibody test results were positive at Screening;

5. Prior exposure to approved or experimental HCV-specific direct-acting antiviral agent;

6. Pregnant female or male with pregnant female partner.

Related Conditions & MeSH terms

• Chronic HCV Infection
• Hepatitis C
• Infection

Intervention

Drug:
• SOF
400 mg tablet administered orally once daily
• DAG181
100 mg capsule administered orally once daily

Locations

Country	Name	City	State
China	Beijing Ditan Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing
China	Beijing YouAn Hospital,Capital Medical University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Chang Chun	Jilin
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Mengchao Hepatobiliary Hospital of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Guangzhou Eighth People's Hospital	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The First Affiliated Hospital of NanChang University	Nanchang	Jiangxi
China	The People's Liberation Army No.81 Hospital	Nanjing	Jiangsu
China	The Second Hospital of Nanjing	Nanjing	Jiangsu
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	The Sixth People's Hospital of Shenyang	Shenyang	Liaoning
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology	Wuhan	Hubei
China	Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	The Fifth People's Hospital of Wuxi	Wuxi	Jiangsu
China	Tangdu Hospital	Xi'an	Shanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	The Affiliated Hospital of Xuzhou Medical Hospital	Xuzhou	Jiangsu
China	People's Hospital of Zhengzhou	Zhengzhou	Henan
China	The Third People's Hospital of Zhenjiang	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	Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy(SVR12)	SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after discontinuation of therapy	Posttreatment Week 12
Primary	Safety and tolerability were evaluated based on adverse events	Collecting all adverse events during the whole study	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 discontinuation of therapy, respectively.	Posttreatment Weeks 4 and 24
Secondary	HCV RNA change from baseline	the quantification of HCV RNA during and after treatment compared with baseline	Up to posttreatment week 24
Secondary	Percentage of subjects with virologic failure	On-treatment virologic failure: confirmed HCV RNA = the lower limit of quantitation (LLOQ) after having previously had HCV RNA confirmed = 1 log10 IU/mL increase in HCV RNA from nadir while on treatment; HCV RNA persistently =the lower limit of quantitation (LLOQ) through 8 weeks of treatment.; Virologic relapse: Confirmed HCV RNA =the lower limit of quantitation (LLOQ) during the posttreatment period having achieved HCV RNA	Up to posttreatment week 24
Secondary	Percentage of subjects with viral resistance to DAG181 and/or SOF	Monitoring HCV virus resistance at baseline, during and after treatment	Up to posttreatment week 24