Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients

June 27, 2019 updated by: Ginkgopharma CO., LTD

A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 1 Hepatitis C Virus Infection.

This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir administered for 12 weeks in patients with Hepatitis C (HCV) genotype1. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • BeiJing YouAn Hospital ,Capital Medical University
      • Beijing, Beijing, China
        • Beijing Ditan Hospital,Capital Medical University
      • Beijing, Beijing, China
        • Beijing Friendship Hospital,Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China
        • Chongqing Public Health Medical Center
      • Chongqing, Chongqing, China
        • Chongqing Sanxia Center Hospital
    • Guangxi Zhuang Autonomous Region
      • Liuzhou, Guangxi Zhuang Autonomous Region, China
        • Liuzhou General Hospital
    • Guizhou
      • Zunyi, Guizhou, China
        • Affiliated Hospital of Zunyi Medical University
    • Hebei
      • Shijiazhuang, Hebei, China
        • The First Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, China
        • The Sixth People's Hospital of Zhengzhou
    • Hubei
      • Wuhan, Hubei, China
        • Tongji hospital affiliated to tongji medical college huazhong university of science and technology
      • Wuhan, Hubei, China
        • Wuhan Medical Treatment Center
    • Jiangsu
      • Wuxi, Jiangsu, China
        • Wuxi No.5 People's Hospital
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical University
    • Jilin
      • Changchun, Jilin, China, 130000
        • The first hospital of JILIN University.
    • Nanning
      • Guangxi, Nanning, China
        • The First Affiliated Hospital of Guangxi Medical University
    • Shanxi
      • Taiyuan, Shanxi, China
        • First Hospital of Shanxi Medical University
    • Sichaun
      • Luzhou, Sichaun, China
        • Traditional Chinese Medical Hospital Affiliated To Southwest Medical University
    • Sichuan
      • Chendu, Sichuan, China
        • Chengdu Public Health Medical Center
      • Chengdu, Sichuan, China
        • Sichuan Province General Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • First Affiliated Hospital of Xinjiang Medical University
      • Ürümqi, Xinjiang, China
        • Traditional Chinese Medical Hospital Uygur Autonomous Region
    • Zhejiang
      • Huzhou, Zhejiang, China
        • Huzhou Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening).
  • HCVRNA greater than 10,000 IU/mL at screening.
  • Participant must be willing and able to comply with the protocol requirements.
  • weight was more than 40 kg.
  • age is between 18-75,either sex.

Exclusion Criteria:

  • Co-infection with hepatitis B virus or human immunodeficiency virus (HIV).
  • Infection with HCV non-genotype 1,or Infection with mixed genotype,or Genotype cannot be confirmed.
  • Medical history of major functional organ transplantation.
  • Suffering from serious blood system disease(such us Thalassemia/Sickle Cell Anemia).
  • Participation in a clinical study within 3 months prior to first dose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Seraprevir and sofosbuvir
Subjects will receive oral tablets of Seraprevir 100mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 12.
Drug: Seraprevir
Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
Other Names:
  • GP205
Drug: Sofosbuvir
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12
Other Names:
  • sovaldi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12）
Time Frame: Posttreatment Week 12
SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 15 IU/mL) 12 weeks following the last dose of study drug.
Posttreatment Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
Time Frame: Posttreatment Week 4
SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.
Posttreatment Week 4
Percentage of Participants Achieving a On-treatment Virologic Response
Time Frame: week 1,week 2,week 4,week8,week 12
Percentage of participants who achieved HCV RNA <LLOQ at week 1,week 2,week 4,week8,week 12.
week 1,week 2,week 4,week8,week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ginkgopharma CO., LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2018

Primary Completion (Anticipated)

July 31, 2019

Study Completion (Anticipated)

November 30, 2019

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP205-1801

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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