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

July 1, 2021 updated by: Zhe-bin Wu, Third Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhang Xiao hong, Professor
  • Phone Number: 2372 020-85253333
  • Email: 1716511502@qq.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 020
        • Recruiting
        • Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Zhe-bin Wu, resident physician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
genotype 3a HCV
genotype 3a hepatitis C
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.
genotype 6 HCV
genotype 6 hepatitis C
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.
genotype 3b HCV
genotype 3b hepatitis C
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR12
Time Frame: 12 weeks
HCV RNA <LLOQ at Week 12 after cessation of treatment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2018

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2018]02-417-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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