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Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Sofosbuvir in Combination With Ribavirin or Simeprevir: Real-life Study of Patients With Hepatitis C Genotype 4

NCT04385407•Beni-Suef University

Summary

A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).

Detailed Description

A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with plasma HCV RNA level \>10,000 IU/L for the two groups.
•Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy.
•Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV

Exclusion Criteria

•coinfected with hepatitis B virus or human immunodeficiency virus infection,
•any cause of liver disease other than HCV GT4 infection;
•liver decompensation,
•hepatocellular carcinoma,
•major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C \>9)
•Participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count \<50,000 cells/mm3)

Key Dates

Start Date

April 1, 2015

Primary Completion Date

July 1, 2016

Completion Date

July 1, 2016

Last Updated

May 12, 2020

Enrollment

203

ACTUAL participants

Conditions

Chronic Hepatitis C Virus Infection

Interventions

Sofosbuvir + Simeprevir + Ribavirin

DRUG

Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

NCT04391985

Chronic Hepatitis C Virus Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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