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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04948801
• Other study ID #: [2018]02-417-01
• Status: Recruiting
• Start date: December 8, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2021
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Zhang Xiao hong, Professor
• Phone: 020-85253333
• Email: 1716511502[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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/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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Epclusa (sofosbuvir and velpatasvir)
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.

Locations

Country	Name	City	State
China	Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR12	HCV RNA	12 weeks