Clinical trial NCT04001608: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Lead sponsor: Ginkgopharma CO., LTD
Sponsor class: INDUSTRY
First posted: 2019-06-28
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12）
timeFrame: Posttreatment Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants Achieving a On-treatment Virologic Response
timeFrame: week 1,week 2,week 4,week8,week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing YouAn Hospital ,Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Chongqing Public Health Medical Center
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Sanxia Center Hospital
state: Chongqing
city: Liuzhou
country: China
facility: Liuzhou General Hospital
state: Guangxi Zhuang Autonomous Region
city: Zunyi
country: China
facility: Affiliated Hospital Of Zunyi Medical University
state: Guizhou
city: Shijiazhuang
country: China
facility: The First Hospital Of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The Sixth People's Hospital Of Zhengzhou
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated To Tongji Medical College Huazhong University Of Science And technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Medical Treatment Center
state: Hubei
city: Wuxi
country: China
facility: Wuxi No.5 People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital OF Xuzhou Medical University
state: Jiangsu
city: Changchun
country: China
facility: The first hospital of JILIN university.
state: Jilin
city: Guangxi
country: China
facility: The First Affiliated Hospital Of Guangxi Medical University
state: Nanning
city: Taiyuan
country: China
facility: First Hospital Of Shanxi Medical University
state: Shanxi
city: Luzhou
country: China
facility: Traditional Chinese Medical Hospital Affiliated To Southwest Medical University
state: Sichaun
city: Chendu
country: China
facility: Chengdu Public Health Medical Center
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Province General Hospital
state: Sichuan
city: Ürümqi
country: China
facility: First Affiliated Hospital Of Xinjiang Medical University
state: Xinjiang
city: Ürümqi
country: China
facility: Traditional Chinese Medical Hospital Uygur Autonomous Region
state: Xinjiang
city: Huzhou
country: China
facility: Huzhou Center Hospital
state: Zhejiang
Study officials:
affiliation: Ginkgo Pharma Co., Ltd.
name: Xuegang Wu
role: STUDY_DIRECTOR
References: