Phase 3 Study of Yimitasvir Phosphate Capsules

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2019-06-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 2 Study of Yimitasvir Phosphate Capsules

NCT03458481

Chronic HCV Infection

COMPLETED PHASE2

The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects

NCT03462173

Chronic Hepatitis c

COMPLETED PHASE1

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

NCT05395416

Chronic HCV Infection

COMPLETED PHASE2/PHASE3

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

NCT02480712

Hepatitis C Virus Infection

COMPLETED PHASE3

Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

NCT03074331

Hepatitis C Virus Infection

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic HCV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SOF 400 mg+DAG181 100 mg

Patients with genotype 1 HCV infection without cirrhosis will receive SOF 400 mg+DAG181 100 mg for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

400 mg tablet administered orally once daily

DAG181

Intervention Type DRUG

100 mg capsule administered orally once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SOF

400 mg tablet administered orally once daily

Intervention Type DRUG

DAG181

100 mg capsule administered orally once daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sofosbuvir Sovaldi® Yimitasvir

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lai Wei, Doctor

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.