Phase 3 Study of Yimitasvir Phosphate Capsules
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
1 other identifier
interventional
362
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2018
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedStudy Start
First participant enrolled
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2019
CompletedMarch 18, 2020
March 1, 2020
12 months
March 26, 2018
March 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Safety and tolerability were evaluated based on adverse events
Collecting all adverse events during the whole study
Up to posttreatment week 24
Secondary Outcomes (4)
Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
HCV RNA change from baseline
Up to posttreatment week 24
Percentage of subjects with virologic failure
Up to posttreatment week 24
Percentage of subjects with viral resistance to DAG181 and/or SOF
Up to posttreatment week 24
Study Arms (1)
SOF 400 mg+DAG181 100 mg
EXPERIMENTALPatients with genotype 1 HCV infection without cirrhosis will receive SOF 400 mg+DAG181 100 mg for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent;
- Male or female, age≥18 years;
- A female subject is eligible to enter the study if it is confirmed that she is:
- 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
- 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.
- 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;
- Male subjects must agree to refrain from sperm donation from the date of screening until 90 days after the last dose of study drugs;
- Confirmation of chronic HCV infection documented by either:
- 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
- A liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection.
- Serological detection of anti-HCV antibodies was positive at screening;
- HCV RNA≥1×104 IU/mL at Screening;
- HCV genotype 1a, 1b, or mixed 1a/1b at screening as determined by the Central Laboratory;
- Classification as treatment naive or treatment experienced;
- Absence of cirrhosis.
You may not qualify if:
- 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;
- Laboratory results outside of acceptable ranges at Screening;
- HBsAg serology test results were positive at Screening;
- HIV antibody test results were positive at Screening;
- Prior exposure to approved or experimental HCV-specific direct-acting antiviral agent;
- Pregnant female or male with pregnant female partner.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Beijing Ditan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100020, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital，Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing YouAn Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, 510060, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Hainan General Hospital
Haikou, Hainan, 570311, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450003, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430010, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410000, China
Xiangya Hospital, Central South University
Changsha, Hunan, 410008, China
The People's Liberation Army No.81 Hospital
Nanjing, Jiangsu, 210002, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003, China
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, 214073, China
The Affiliated Hospital of Xuzhou Medical Hospital
Xuzhou, Jiangsu, 221002, China
The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, 212004, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, 110006, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200020, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201500, China
Tangdu Hospital
Xi’an, Shanxi, 710038, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lai Wei, Doctor
Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2018
First Posted
April 3, 2018
Study Start
April 17, 2018
Primary Completion
March 28, 2019
Study Completion
June 25, 2019
Last Updated
March 18, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share