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Pharmacokinetics of Asparaginase and Antibody Formation in Interfant-06

NCT01025804 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2016-03-04

No results posted yet for this study

Summary

Asparaginase is an important drug in the treatment of childhood leukemia including in infant (\<1 year). The prognosis for infants is bad.

Information about drug metabolism in neonates and infants is scarce as well as the reactions of an immature immune system to foreign proteins. The aims of this study is to describe the metabolism (pharmacokinetics) of asparaginase after administration intramuscularly and to evaluate the formation of antibodies against the drug (enzyme) during treatment in order to optimize the asparaginase treatment in infants in the future.

Conditions

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Birgitte K Albertsen, MD

Eligibility

Min Age
1 Hour
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Denmark
  • Finland
  • Iceland
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

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 NCT01025804 on ClinicalTrials.gov