Phase 3 Study of Yimitasvir Phosphate Capsules

Phase 3

Completed

• Conditions: Chronic HCV Infection
• Interventions: Drug: SOF; Drug: DAG181

• Registration Number: NCT03487107
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

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 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.

Study Timeline

• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-04-01
• Study First Posted: 2018-04-03
• Study Start: 2018-04-17
• Primary Completion: 2019-03-28
• Study Completion: 2019-06-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy(SVR12)	Posttreatment Week 12	SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after discontinuation of therapy
Safety and tolerability were evaluated based on adverse events	Up to posttreatment week 24	Collecting all adverse events during the whole study

Secondary Outcome Measures

Name	Time	Method
HCV RNA change from baseline	Up to posttreatment week 24	the quantification of HCV RNA during and after treatment compared with baseline
Percentage of subjects with virologic failure	Up to posttreatment week 24	1. On-treatment virologic failure: 1. confirmed HCV RNA ≥ the lower limit of quantitation (LLOQ) after having previously had HCV RNA \<the lower limit of quantitation (LLOQ) while on treatment; 2. confirmed ≥ 1 log10 IU/mL increase in HCV RNA from nadir while on treatment; 3. HCV RNA persistently ≥the lower limit of quantitation (LLOQ) through 8 weeks of treatment.; 2. Virologic relapse: 1. Confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) during the posttreatment period having achieved HCV RNA \<the lower limit of quantitation (LLOQ) at last on-treatment visit.
Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR24 were defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 4 and 24 weeks after discontinuation of therapy, respectively.
Percentage of subjects with viral resistance to DAG181 and/or SOF	Up to posttreatment week 24	Monitoring HCV virus resistance at baseline, during and after treatment

Trial Locations

Locations (35)

Beijing Ditan Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing YouAn Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Mengchao Hepatobiliary Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Guangzhou Eighth People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

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