Back to resultsStudy of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients
Primary Purpose
Hepatitis C Virus Infection
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Seraprevir
Sofosbuvir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection
Eligibility Criteria
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
Sites / Locations
- Beijing Ditan Hospital,Capital Medical University
- Beijing Friendship Hospital,Capital Medical University
- Beijing YouAn Hospital ,Capital Medical University
- Chongqing Public Health Medical Center
- Chongqing Sanxia Center Hospital
- Liuzhou General Hospital
- Affiliated Hospital Of Zunyi Medical University
- The First Hospital Of Hebei Medical University
- The Sixth People's Hospital Of Zhengzhou
- Tongji Hospital Affiliated To Tongji Medical College Huazhong University Of Science And technology
- Wuhan Medical Treatment Center
- Wuxi No.5 People's Hospital
- The Affiliated Hospital OF Xuzhou Medical University
- The first hospital of JILIN university.
- The First Affiliated Hospital Of Guangxi Medical University
- First Hospital Of Shanxi Medical University
- Traditional Chinese Medical Hospital Affiliated To Southwest Medical University
- Chengdu Public Health Medical Center
- Sichuan Province General Hospital
- First Affiliated Hospital Of Xinjiang Medical University
- Traditional Chinese Medical Hospital Uygur Autonomous Region
- Huzhou Center Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Seraprevir and sofosbuvir
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12）
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.
Secondary Outcome Measures
Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.
Percentage of Participants Achieving a On-treatment Virologic Response
Percentage of participants who achieved HCV RNA <LLOQ at week 1,week 2,week 4,week8,week 12.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04001608
Brief Title
Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 17, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ginkgopharma CO., LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seraprevir and sofosbuvir
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Seraprevir
Other Intervention Name(s)
GP205
Intervention Description
Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
sovaldi
Intervention Description
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12）
Description
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.
Time Frame
Posttreatment Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
Description
SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.
Time Frame
Posttreatment Week 4
Title
Percentage of Participants Achieving a On-treatment Virologic Response
Description
Percentage of participants who achieved HCV RNA <LLOQ at week 1,week 2,week 4,week8,week 12.
Time Frame
week 1,week 2,week 4,week8,week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuegang Wu
Organizational Affiliation
Ginkgo Pharma Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Ditan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Friendship Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing YouAn Hospital ,Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing Public Health Medical Center
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Chongqing Sanxia Center Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Liuzhou General Hospital
City
Liuzhou
State/Province
Guangxi Zhuang Autonomous Region
Country
China
Facility Name
Affiliated Hospital Of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
Country
China
Facility Name
The First Hospital Of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The Sixth People's Hospital Of Zhengzhou
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Tongji Hospital Affiliated To Tongji Medical College Huazhong University Of Science And technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Wuhan Medical Treatment Center
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Wuxi No.5 People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
The Affiliated Hospital OF Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
The first hospital of JILIN university.
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
The First Affiliated Hospital Of Guangxi Medical University
City
Guangxi
State/Province
Nanning
Country
China
Facility Name
First Hospital Of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Traditional Chinese Medical Hospital Affiliated To Southwest Medical University
City
Luzhou
State/Province
Sichaun
Country
China
Facility Name
Chengdu Public Health Medical Center
City
Chendu
State/Province
Sichuan
Country
China
Facility Name
Sichuan Province General Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
First Affiliated Hospital Of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
Traditional Chinese Medical Hospital Uygur Autonomous Region
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
Huzhou Center Hospital
City
Huzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients
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