MedTrace Logo

Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

NCT01472055 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2014-08-20

No results posted yet for this study

Summary

The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.

Conditions

Interventions

DRUG

Fludarabine

1. Fludarabine 40 mg/m\^2 once a day intravenous administration over 30 min 2. Development of sampling-minimized analysis method through individualized pharmacokinetics Sampling time: 0hr (pre-dose), 30 min (post-dose), 1hr, 3hr, 5hr, 8hr, 24hr 3. Population pharmacokinetics analysis 4. Comparative analysis of population pharmacokinetics in pediatric and adult patients 5. Analysis of population pharmacokinetics, toxicity, engraftment rate, survival rate

Sponsors & Collaborators

  • Ministry of Food and Drug Safety, Korea

    collaborator OTHER_GOV

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hyoung Jin Kang, MD., PhD · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01472055 on ClinicalTrials.gov