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Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4

NCT02772744 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2017-10-10

No results posted yet for this study

Summary

This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of Egyptian ministry of health and population. The primary outcomes are safety of the treatment and the sustained virologic response 12 weeks after discontinuation of therapy. For the secondary outcomes, investigators will measure the change in health related quality of life and investigate the genetic sequence of viral RNA of resistant patients.

Conditions

  • Hepatitis C

Interventions

DRUG

Daclatasvir 60 MG Oral Tablet [Daklinza]

Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein

DRUG

Sofosbuvir 400 MG Oral Tablet [Sovaldi]

Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor

DRUG

Ribavirin Oral Product

Ribavirin (twice-daily) dosed according to body weight (\<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily)

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Samah A Loutfy · National Cancer Institute, Cairo University, Cairo, Egypt

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-12-31
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02772744 on ClinicalTrials.gov