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

NCT04948801 | Unknown DMC FDA Drug

• 1 other identifier: [2018]02-417-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• SVR12

  HCV RNA \<LLOQ at Week 12 after cessation of treatment

  12 weeks

Study Arms (3)

genotype 3a HCV

genotype 3a hepatitis C

Drug: Epclusa (sofosbuvir and velpatasvir)

genotype 6 HCV

genotype 6 hepatitis C

Drug: Epclusa (sofosbuvir and velpatasvir)

genotype 3b HCV

genotype 3b hepatitis C

Drug: Epclusa (sofosbuvir and velpatasvir)

Interventions

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.

genotype 3a HCV; genotype 3b HCV; genotype 6 HCV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The groups or cohorts will be selected from people who was diagnosed with hepatitis c at the hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 020, China

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination; Sofosbuvir; velpatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Central Study Contacts

Zhang Xiao hong, Professor

CONTACT

020-85253333; 1716511502@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: July 2, 2021
• Study Start: December 8, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)