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

Hepatitis C Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04111367
• Other study ID #: GP205-1901
• Status: Recruiting
• Phase: Phase 2
• Start date: April 3, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: July 2019
• Source: Ginkgopharma CO., LTD
• Contact: Junqi Niu
• Phone: 0431-88782013
• Email: junqiniu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital,Capital Medical University	Beijing	Beijing
China	The first hospital of JILIN University.	Changchun	Jilin
China	The First Affiliated Hospital Of Guangxi Medical University	Guangxi	Nanning
China	Liuzhou General Hospital	Liuzhou	Guangxi Zhuang Autonomous Region

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