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

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

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).

Study Overview

• Status: Unknown
• Conditions: Hepatitis C Virus Infection
• Intervention / Treatment: Drug: Seraprevir; Drug: Sofosbuvir

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Ditan Hospital,Capital Medical University
      • Contact: Huichun Xing
  • Guangxi Zhuang Autonomous Region
    • Liuzhou, Guangxi Zhuang Autonomous Region, China
      • Recruiting
      • Liuzhou General Hospital
      • Contact: Xiaofeng Wen
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • The first hospital of JILIN University.
      • Contact: Junqi Niu; Phone Number: 0431-88782013; Email: junqiniu@aliyun.com
  • Nanning
    • Guangxi, Nanning, China
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Minghua Su

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ginkgopharma CO., LTD

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2019
• Primary Completion (ANTICIPATED): April 30, 2020
• Study Completion (ANTICIPATED): August 31, 2020

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Blood-Borne Infections; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Infections; Communicable Diseases; Hepatitis; Hepatitis A; Hepatitis C; Virus Diseases; Anti-Infective Agents; Antiviral Agents; Sofosbuvir
• Other Study ID Numbers: GP205-1901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No