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Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children

NCT05091008 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-10-25

No results posted yet for this study

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.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

proper history was taken. HCV genotyping was done revealed GT 4 in all included patients. Basic ECG and abdominal US were performed prior to treatment. Concomitant HBV infection was excluded by HBs Ag and anti-HBc antibody HIV screening was done prior to treatment. Basic investigations were done prior to therapy. All included patients received Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), orally once daily at a fixed time with or without food for 12 weeks. Regular visits were arranged at 4, 8, and 12 weeks with easy access to the pediatric hepatology unit and the treating physician if any urgent problem in between the visits. Every visit, laboratory investigations were checked. Adverse events (after excluding other possible causes) were reported for the safety profile of the drug. The efficacy of the drug, HCV-RNA was assessed by quantitative real-time PCR at 4 weeks and after the end of the treatment course (12 weeks)

Sponsors & Collaborators

  • Mansoura University Children Hospital

    lead OTHER

Principal Investigators

  • Ahmed M Noaman, MD · Lecturer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-08-30
Completion
2020-03-10

Countries

  • Egypt

Study Locations

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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 NCT05091008 on ClinicalTrials.gov