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Phase 3 Study of Yimitasvir Phosphate Capsules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487107
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic HCV Infection Drug: SOF Drug: DAG181 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 17, 2018
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : June 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C
Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: 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.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • sofosbuvir
  • Sovaldi®

Drug: DAG181
100 mg capsule administered orally once daily
Other Name: Yimitasvir




Primary Outcome Measures :
  1. Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy(SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after discontinuation of therapy

  2. Safety and tolerability were evaluated based on adverse events [ Time Frame: Up to posttreatment week 24 ]
    Collecting all adverse events during the whole study


Secondary Outcome Measures :
  1. Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) [ Time Frame: 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.

  2. HCV RNA change from baseline [ Time Frame: Up to posttreatment week 24 ]
    the quantification of HCV RNA during and after treatment compared with baseline

  3. Percentage of subjects with virologic failure [ Time Frame: 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.

  4. Percentage of subjects with viral resistance to DAG181 and/or SOF [ Time Frame: Up to posttreatment week 24 ]
    Monitoring HCV virus resistance at baseline, during and after treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487107


Locations
Show Show 35 study locations
Sponsors and Collaborators
Sunshine Lake Pharma Co., Ltd.
Investigators
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Study Chair: Lai Wei, Doctor Peking University People's Hospital

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Responsible Party: Sunshine Lake Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03487107    
Other Study ID Numbers: PCD-DDAG181PA-16-007
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunshine Lake Pharma Co., Ltd.:
Chronic Genotype 1 HCV Infection
Additional relevant MeSH terms:
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Infection
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Sofosbuvir
Yimitasvir
Antiviral Agents
Anti-Infective Agents