Back to resultsStudy of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients
Primary Purpose
Hepatitis C Virus Infection
Status
Unknown status
Phase
Phase 2
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 2,3,6 infection (confirmed at screening). HCV RNA 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 2,3,6,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 UniversityRecruiting
- Liuzhou General HospitalRecruiting
- The first hospital of JILIN University.Recruiting
- The First Affiliated Hospital Of Guangxi Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Genotype 2 and 6 Subjects
Genotype 3 Subjects
Arm Description
Genotype 2 and 6 Subjects will receive oral tablets of Seraprevir 200mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 12
Genotype 3 Subjects will receive oral tablets of Seraprevir 200mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 24
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.
Full Information
NCT ID
NCT04111367
First Posted
September 29, 2019
Last Updated
September 30, 2019
Sponsor
Ginkgopharma CO., LTD
1. Study Identification
Unique Protocol Identification Number
NCT04111367
Brief Title
Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients
Official Title
A Phase IIa, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 2,3,6 Hepatitis C Virus Infection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (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 in patients with Hepatitis C (HCV) genotype2,3,6. 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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Genotype 2 and 6 Subjects
Arm Type
Experimental
Arm Description
Genotype 2 and 6 Subjects will receive oral tablets of Seraprevir 200mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 12
Arm Title
Genotype 3 Subjects
Arm Type
Experimental
Arm Description
Genotype 3 Subjects will receive oral tablets of Seraprevir 200mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 24
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，the other group will receive the same dose for 24 weeks.
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,the other group will receive the same dose for 24 weeks.
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
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 2,3,6 infection (confirmed at screening). HCV RNA 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 2,3,6,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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junqi Niu
Phone
0431-88782013
Email
junqiniu@aliyun.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huichun Xing
Facility Name
Liuzhou General Hospital
City
Liuzhou
State/Province
Guangxi Zhuang Autonomous Region
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Wen
Facility Name
The first hospital of JILIN University.
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junqi Niu
Phone
0431-88782013
Email
junqiniu@aliyun.com
Facility Name
The First Affiliated Hospital Of Guangxi Medical University
City
Guangxi
State/Province
Nanning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minghua Su
12. IPD Sharing Statement
Learn more about this trial
Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients
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