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NCT04001608 Clinical Trial

Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients

Hepatitis C Virus Infection Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04001608
Other study ID # GP205-1801
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 17, 2018
Est. completion date November 30, 2019

Study information
Verified date June 2019
Source Ginkgopharma CO., LTD
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 206
Est. completion date November 30, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
China Beijing Ditan Hospital,Capital Medical University Beijing Beijing
China Beijing Friendship Hospital,Capital Medical University Beijing Beijing
China Beijing YouAn Hospital ,Capital Medical University Beijing Beijing
China The first hospital of JILIN university. Changchun Jilin
China Chengdu Public Health Medical Center Chendu Sichuan
China Sichuan Province General Hospital Chengdu Sichuan
China Chongqing Public Health Medical Center Chongqing Chongqing
China Chongqing Sanxia Center Hospital Chongqing Chongqing
China The First Affiliated Hospital Of Guangxi Medical University Guangxi Nanning
China Huzhou Center Hospital Huzhou Zhejiang
China Liuzhou General Hospital Liuzhou Guangxi Zhuang Autonomous Region
China Traditional Chinese Medical Hospital Affiliated To Southwest Medical University Luzhou Sichaun
China The First Hospital Of Hebei Medical University Shijiazhuang Hebei
China First Hospital Of Shanxi Medical University Taiyuan Shanxi
China First Affiliated Hospital Of Xinjiang Medical University Ürümqi Xinjiang
China Traditional Chinese Medical Hospital Uygur Autonomous Region Ürümqi Xinjiang
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 Sixth People's Hospital Of Zhengzhou Zhengzhou Henan
China Affiliated Hospital Of Zunyi Medical University Zunyi Guizhou

Sponsors (1)
Lead Sponsor Collaborator
Ginkgopharma CO., LTD

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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. Posttreatment Week 4
Secondary Percentage of Participants Achieving a On-treatment Virologic Response Percentage of participants who achieved HCV RNA week 1,week 2,week 4,week8,week 12
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