Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients
NCT ID: NCT04001608
Last Updated: 2019-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
206 participants
INTERVENTIONAL
2018-10-17
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Seraprevir
Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
Sofosbuvir
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12
Interventions
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Seraprevir
Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
Sofosbuvir
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Ginkgopharma CO., LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Xuegang Wu
Role: STUDY_DIRECTOR
Ginkgo Pharma Co., Ltd.
Locations
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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
Liuzhou, 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, 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
Countries
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Other Identifiers
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GP205-1801
Identifier Type: -
Identifier Source: org_study_id