Status:
COMPLETED
Phase 3 Study of Yimitasvir Phosphate Capsules
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Chronic HCV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Detailed 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 in...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2019
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT03487107
Start Date
April 17 2018
End Date
June 25 2019
Last Update
March 18 2020
Active Locations (35)
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1
Beijing Ditan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100020
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
4
Beijing Friendship Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100050