Safety and Efficacy of Different Antiviral Regimens for Hepatitis C Virus Relapse

NCT04662138 | Unknown

• 1 other identifier: 0304769
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of hepatitis C virus (HCV) Direct Acting Antivirals (DAAs) is to achieve undetectable HCV RNA in the blood. A response that should be maintained for at least 12 weeks from completion of therapy. This is called sustained virological response (SVR) which corresponds to cure of HCV infection as risk of later relapse is very small. SVR is important to achieve improvement in liver necroinflammation and fibrosis and to decrease complications of cirrhosis. Failing to achieve SVR after treatment requires another regimen for these experienced patients. Real-world data are always needed to evaluate and improve our practices. Here investigators aim to assess tolerability and efficacy of different regimens used for management of genotype 4 HCV relapse.

Conditions

Hepatitis C; Relapse; Antivirals

Outcome Measures

Primary Outcomes (1)

• Sustained virological response

  12 weeks after completion of treatment

Interventions

directly acting antivirals DRUG

Different regimens given for genotype 4 relapse: Sofosbuvir/velpatasvir/voxilaprevir ±ribavirin; sofosbuvir/velpatasvir ±ribavirin; ombitasvir/paritaprevir/ritonavir+ ribavirin

Eligibility Criteria

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

Study Population

All patients with HCV relapse after sofosbuvir plus either NS5A or protease inhibitor who will start another HCV treatment at Alexandria University Viral Hepatitis Treatment Unit or Alexandria University Liver Clinics in the period from 24/8/2020 to 23/8/2021.

You may qualify if:

• all patients with HCV relapse after sofosbuvir plus either Non-structural protein 5 A (NS5A) or protease inhibitor.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University.

Alexandria, 21131, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed Kamal

CONTACT

01279734654; Ahmed.Kamal@alexmed.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: August 24, 2020
• Primary Completion: May 28, 2022
• Study Completion: May 28, 2022
• Last Updated: December 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)