SOF/VEL RBV: Efficacy and Safety in GT 3 and 6 HCV Patients

  • STATUS
    Recruiting
  • days left to enroll
    65
  • participants needed
    150
  • sponsor
    Third Affiliated Hospital, Sun Yat-Sen University
Updated on 9 July 2021

Summary

150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated patients will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered Epclusa each plus Ribavirin for 12 weeks.

Description

This is a Prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of SOF/VELRBV in Chinese patients infected by HCV GT-3 and 6. 150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated cirrhosis will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered one pill of Epclusa each plus Ribavirin for 12 weeks.Demographic, clinical, adverse event and virological data were be collected throughout treatment and post-treatment follow-up.

Details
Condition Hepatitis C, Hepatitis C virus
Treatment Epclusa (sofosbuvir and velpatasvir)
Clinical Study IdentifierNCT04948801
SponsorThird Affiliated Hospital, Sun Yat-Sen University
Last Modified on9 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

HCV RNA 15 IU/Ml at Screening
HCV genotype 3a ,3b and 6
Hepatitis C without decompensated cirrhosis of the liver

Exclusion Criteria

Patients failed to previous NS5A-containing DAAs therapy
Decompensated cirrhosis
HCC
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
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