Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients

Sponsor

Ginkgopharma CO., LTD (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04111367

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

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 in patients with Hepatitis C (HCV) genotype2,3,6. 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 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase IIa, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 2,3,6 Hepatitis C Virus Infection

Actual Study Start Date :

Apr 3, 2019

Anticipated Primary Completion Date :

Apr 30, 2020

Anticipated Study Completion Date :

Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Genotype 2 and 6 Subjects Genotype 2 and 6 Subjects will receive oral tablets of Seraprevir 200mg 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，the other group will receive the same dose for 24 weeks. Other Names: GP205 Drug: Sofosbuvir Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12,the other group will receive the same dose for 24 weeks. Other Names: sovaldi
Experimental: Genotype 3 Subjects Genotype 3 Subjects will receive oral tablets of Seraprevir 200mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 24	Drug: Seraprevir Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12，the other group will receive the same dose for 24 weeks. Other Names: GP205 Drug: Sofosbuvir Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12,the other group will receive the same dose for 24 weeks. Other Names: sovaldi

Arm

Intervention/Treatment

Experimental: Genotype 2 and 6 Subjects

Genotype 2 and 6 Subjects will receive oral tablets of Seraprevir 200mg 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，the other group will receive the same dose for 24 weeks.

Other Names:

GP205

Drug: Sofosbuvir

Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12,the other group will receive the same dose for 24 weeks.

Other Names:

sovaldi

Experimental: Genotype 3 Subjects

Genotype 3 Subjects will receive oral tablets of Seraprevir 200mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 24

Drug: Seraprevir

Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12，the other group will receive the same dose for 24 weeks.

Other Names:

GP205

Drug: Sofosbuvir

Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12,the other group will receive the same dose for 24 weeks.

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.

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 2,3,6 infection (confirmed at screening). HCV RNA 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 2,3,6,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	Liuzhou General Hospital	Liuzhou	Guangxi Zhuang Autonomous Region	China
3	The first hospital of JILIN University.	Changchun	Jilin	China	130000
4	The First Affiliated Hospital Of Guangxi Medical University	Guangxi	Nanning	China