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Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy

NCT03903185 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-22

No results posted yet for this study

Summary

This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of ledipasvir, sofosbuvir, and GS-331007 metabolite in HCV infected children with hematological malignancy.

In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food.

Conditions

  • Hepatitis C, Chronic
  • Hematologic Malignancy

Interventions

DRUG

Ledipasvir / Sofosbuvir Oral Product

45 mg of ledipasvir and 200 mg of sofosbuvir orally, once daily with food

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Manal H Elsayed, MD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2023-07-01
Completion
2023-08-15

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 NCT03903185 on ClinicalTrials.gov