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

NCT ID: NCT04662138

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-24

Study Completion Date

2022-05-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C Relapse Antivirals

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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directly acting antivirals

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alexandria University.

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Kamal

Role: CONTACT

Phone: 01279734654

Email: [email protected]

Facility Contacts

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Ahmed Kamal

Role: primary

Other Identifiers

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0304769

Identifier Type: -

Identifier Source: org_study_id