Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients
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.
1 other identifier
interventional
206
1 country
22
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2018
Shorter than P25 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2018
CompletedFirst Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedJune 28, 2019
June 1, 2019
10 months
June 21, 2019
June 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Posttreatment Week 12
Secondary Outcomes (2)
Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
Posttreatment Week 4
Percentage of Participants Achieving a On-treatment Virologic Response
week 1,week 2,week 4,week8,week 12
Study Arms (1)
Seraprevir and sofosbuvir
EXPERIMENTALSubjects 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.
Interventions
Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing YouAn Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
Chongqing Public Health Medical Center
Chongqing, Chongqing Municipality, China
Chongqing Sanxia Center Hospital
Chongqing, Chongqing Municipality, China
Liuzhou General Hospital
Liuchow, Guangxi, China
Affiliated Hospital Of Zunyi Medical University
Zunyi, Guizhou, China
The First Hospital Of Hebei Medical University
Shijiazhuang, Hebei, China
The Sixth People's Hospital Of Zhengzhou
Zhengzhou, Henan, China
Tongji Hospital Affiliated To Tongji Medical College Huazhong University Of Science And technology
Wuhan, Hubei, China
Wuhan Medical Treatment Center
Wuhan, Hubei, China
Wuxi No.5 People's Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital OF Xuzhou Medical University
Xuzhou, Jiangsu, China
The first hospital of JILIN university.
Changchun, Jilin, 130000, China
The First Affiliated Hospital Of Guangxi Medical University
Guangxi, Nanning, China
First Hospital Of Shanxi Medical University
Taiyuan, Shanxi, China
Traditional Chinese Medical Hospital Affiliated To Southwest Medical University
Luzhou, Sichaun, China
Chengdu Public Health Medical Center
Chengdu, Sichuan, China
Sichuan Province General Hospital
Chengdu, Sichuan, China
First Affiliated Hospital Of Xinjiang Medical University
Ürümqi, Xinjiang, China
Traditional Chinese Medical Hospital Uygur Autonomous Region
Ürümqi, Xinjiang, China
Huzhou Center Hospital
Huzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xuegang Wu
Ginkgo Pharma Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 28, 2019
Study Start
October 17, 2018
Primary Completion
July 31, 2019
Study Completion
November 30, 2019
Last Updated
June 28, 2019
Record last verified: 2019-06