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Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT04111367•Ginkgopharma CO., LTD

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (4)

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Liuzhou General Hospital

Liuchow, Guangxi, China

The first hospital of JILIN University.

Changchun, Jilin, China

The First Affiliated Hospital Of Guangxi Medical University

Guangxi, Nanning, China

Key Dates

Start Date

April 3, 2019

Primary Completion Date

April 30, 2020

Completion Date

August 31, 2020

Last Updated

October 1, 2019

Enrollment

ESTIMATED participants

Conditions

Hepatitis C Virus Infection

Interventions

Seraprevir

DRUG

Sofosbuvir

DRUG

Contacts

Junqi Niu

CONTACT

0431-88782013 junqiniu@aliyun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

Relinking Diagnosed But Untreated HCV Patients Back Into Care.

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