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Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naรฏve Children - Trial NCT05091008

Access comprehensive clinical trial information for NCT05091008 through Pure Global AI's free database. This Phase 2 trial is sponsored by Mansoura University Children Hospital and is currently Completed. The study focuses on Hepatitis C, Chronic. Target enrollment is 50 participants.

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NCT05091008
Phase 2
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05091008
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Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naรฏve Children
The Safety and Efficacy of Ledipasvir/Sofosbuvir in the Treatment of Chronic Hepatitis C Virus Infection in Naรฏve Children

Study Focus

Hepatitis C, Chronic

Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

Interventional

drug

Sponsor & Location

Mansoura University Children Hospital

Mansoura, Egypt

Timeline & Enrollment

Phase 2

Mar 01, 2018

Mar 10, 2020

50 participants

Primary Outcome

Evaluate the efficacy of Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), in children with treatment-Naรฏve, chronic HCV infection, genotype 4.,Evaluate the efficacy of Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), in children with treatment-Naรฏve, chronic HCV infection, genotype 4.

Summary

Chronic hepatitis C virus (HCV) infection represents a crucial health problem in children
 that greatly influence their quality of life. Many efforts have been directed toward the
 investment of effective drugs with high safety profiles and with oral administration for
 better compliance. The development of a new direct-acting antiviral (DAA) made it possible to
 achieve these goals.

ICD-10 Classifications

Chronic viral hepatitis C
Acute hepatitis C
Chronic hepatitis, unspecified
Chronic viral hepatitis
Chronic viral hepatitis, unspecified

Data Source

ClinicalTrials.gov

NCT05091008

Non-Device Trial