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

Sponsor

Ginkgopharma CO., LTD (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04001608

Collaborator

(none)

206

Enrollment

Locations

Arm

13.4

Anticipated Duration (Months)

9.4

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection	Drug: Seraprevir Drug: Sofosbuvir	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

206 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Oct 17, 2018

Anticipated Primary Completion Date :

Jul 31, 2019

Anticipated Study Completion Date :

Nov 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Seraprevir Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12 Other Names: GP205 Drug: Sofosbuvir Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12 Other Names: sovaldi

Arm

Intervention/Treatment

Experimental: 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.

Drug: Seraprevir

Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12

Other Names:

GP205

Drug: Sofosbuvir

Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12

Other Names:

sovaldi

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12） [Posttreatment Week 12]
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) [Posttreatment Week 4]
SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.
Percentage of Participants Achieving a On-treatment Virologic Response [week 1,week 2,week 4,week8,week 12]
Percentage of participants who achieved HCV RNA <LLOQ at week 1,week 2,week 4,week8,week 12.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Ditan Hospital,Capital Medical University	Beijing	Beijing	China
2	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing	China
3	Beijing YouAn Hospital ,Capital Medical University	Beijing	Beijing	China
4	Chongqing Public Health Medical Center	Chongqing	Chongqing	China
5	Chongqing Sanxia Center Hospital	Chongqing	Chongqing	China
6	Liuzhou General Hospital	Liuzhou	Guangxi Zhuang Autonomous Region	China
7	Affiliated Hospital Of Zunyi Medical University	Zunyi	Guizhou	China
8	The First Hospital Of Hebei Medical University	Shijiazhuang	Hebei	China
9	The Sixth People's Hospital Of Zhengzhou	Zhengzhou	Henan	China
10	Tongji Hospital Affiliated To Tongji Medical College Huazhong University Of Science And technology	Wuhan	Hubei	China
11	Wuhan Medical Treatment Center	Wuhan	Hubei	China
12	Wuxi No.5 People's Hospital	Wuxi	Jiangsu	China
13	The Affiliated Hospital OF Xuzhou Medical University	Xuzhou	Jiangsu	China
14	The first hospital of JILIN university.	Changchun	Jilin	China	130000
15	The First Affiliated Hospital Of Guangxi Medical University	Guangxi	Nanning	China
16	First Hospital Of Shanxi Medical University	Taiyuan	Shanxi	China
17	Traditional Chinese Medical Hospital Affiliated To Southwest Medical University	Luzhou	Sichaun	China
18	Chengdu Public Health Medical Center	Chendu	Sichuan	China
19	Sichuan Province General Hospital	Chengdu	Sichuan	China
20	First Affiliated Hospital Of Xinjiang Medical University	Ürümqi	Xinjiang	China
21	Traditional Chinese Medical Hospital Uygur Autonomous Region	Ürümqi	Xinjiang	China
22	Huzhou Center Hospital	Huzhou	Zhejiang	China