NCT02772744

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2016-05-13
• Last updated: 2017-10-10