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Eight Weeks Sofosbovir/Ledipasvir in HCV Infected Children Aged 4 to 10 Years

NCT03764345 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-09-17

No results posted yet for this study

Summary

Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12 to 17 years. Younger children are still on the wait list for treatment. The current study aimed to treat children aged between 3 and 12 years with half the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).

Conditions

  • Hepatitis C, Chronic
  • Children, Only

Interventions

DRUG

Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)

Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks

Sponsors & Collaborators

  • National Liver Institute, Egypt

    lead OTHER

Principal Investigators

  • Behairy E Behairy, Prof · National Liver Institute, Menoufia University

  • Hanaa A El-Araby, Prof · National Liver Institute, Menoufia University

  • Mohamed A El-Guindi, Prof · National Liver Institute, Menoufia University

  • Hosam M Basiouny, MD · National Liver Institute, Menoufia University

  • Ola A Fouad, MD · National Liver Institute, Menoufia University

  • Ayman M Marey, Prof · Faculty of Medicine, Zagazig University

  • Bassam A Ayoub, MD · National Liver Institute, Menoufia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2019-07-02
Completion
2019-07-02

Countries

  • Egypt

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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 NCT03764345 on ClinicalTrials.gov