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PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders

NCT04353986 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-03-06

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 sofosbuvir, ledipasvir and sofosbuvir metabolite (GS-331007) in HCV infected children with hematological Disorders. to develop predictive pharmacokinetic model for the 3 moieties in the studied population.

In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 400 mg of sofosbuvir and 90 mg of ledipasvir(SOF/LED) orally, once daily with food.

Conditions

  • HCV Infection
  • Beta Thalassemia Major

Interventions

DRUG

Sofosbuvir and Ledipasvir

fixed dose tablet containing 400 mg sofosbuvir and 90 mg ledipasvir

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Manal H El-Sayed, M.D · Director of MARSI-CRC

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
2018-06-11
Primary Completion
2023-04-30
Completion
2023-12-31

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 NCT04353986 on ClinicalTrials.gov