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

Phase 3

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: Seraprevir; Drug: Sofosbuvir

• Registration Number: NCT04001608
• Lead Sponsor: Ginkgopharma CO., LTD

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-17
• Status Verified: 2019-06
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-27
• Last Update Submitted: 2019-06-27
• Study First Posted: 2019-06-28
• Last Update Posted: 2019-06-28
• Primary Completion: 2019-07-31
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seraprevir and sofosbuvir	Seraprevir	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.
Seraprevir and sofosbuvir	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (22)

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

Chongqing Public Health Medical Center; 🇨🇳 Chongqing, Chongqing, China

Chongqing Sanxia Center Hospital; 🇨🇳 Chongqing, Chongqing, China

Liuzhou General Hospital; 🇨🇳 Liuzhou, Guangxi Zhuang Autonomous Region, China

Affiliated Hospital Of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China

The First Hospital Of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The Sixth People's Hospital Of Zhengzhou; 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital Affiliated To Tongji Medical College Huazhong University Of Science And technology; 🇨🇳 Wuhan, Hubei, China

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