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

NCT04948801 — Unknown, 150 participants, Third Affiliated Hospital, Sun Yat-Sen University

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SOF/VEL±RBV: Real-World Efficacy and Safety in GT 3 and 6 HCV Patients in China

RegistryNCT04948801
StatusUnknown
Study typeObservational
Enrollment150 (Estimated)
SponsorThird Affiliated Hospital, Sun Yat-Sen University (Other)
ConditionsHepatitis C
InterventionsEpclusa (sofosbuvir and velpatasvir) (Drug)
Datesstart 2018-12-08, primary completion 2021-12-01 (estimated), completion 2021-12-30 (estimated), first posted 2021-07-02, last updated 2021-07-02
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Hepatitis C All trials of Epclusa (sofosbuvir and velpatasvir)

-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.

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+Detailed description

This is a Prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of SOF/VEL±RBV 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.

+Arms and interventions

ArmTypeInterventionsDescription
genotype 3a HCVDrug: Epclusa (sofosbuvir and velpatasvir)genotype 3a hepatitis C
genotype 6 HCVDrug: Epclusa (sofosbuvir and velpatasvir)genotype 6 hepatitis C
genotype 3b HCVDrug: Epclusa (sofosbuvir and velpatasvir)genotype 3b hepatitis C
  • Epclusa (sofosbuvir and velpatasvir) (Drug): Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

+Outcome measures

Primary outcomes

  • SVR12 [12 weeks]: HCV RNA <LLOQ at Week 12 after cessation of treatment

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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).

+Locations (1)

FacilityCityCountryStatus
Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, GuangdongChinaRecruiting