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Therapeutic Drug Monitoring (TDM) of Voriconazole and Correlation With CYP2C19 Genotype in Korean Populations

Sponsor
The Catholic University of Korea (Other)
Overall Status
Unknown status
CT.gov ID
NCT00673348
Collaborator
(none)
40
Enrollment
2
Locations
23
Duration (Months)
20
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Voriconazole (VCZ), the antifungal drug active against Candida and Aspergillus is a substrate of CYP2C19, whose proportion of poor metabolizers is about ~20% in Asian population. The AUC's of VCZ differs over 4 folds by CYP2C19 genotypes of homozygotic wild type, heterozygote, and homozygotic poor metabolizers. The Asian population enrolled in the metabolism of VCZ were mainly Japanese and Chinese, without Korean subjects. The proportion of poor metabolizers in Korean population is known to be around 12% (Pharmacogenetics. 1996 Dec;6(6):547-51). The importance of CYP2C19 genotypes on the pharmacokinetics (PK) of voriconazole is well established, Hence, it is desirable to individualize the dosage regimen of VCZ according to the genotypes of patients. Fungal infection in immunocompromised patients is a life threatening condition which needs critical care. Although the PK change by genotypes are well known, its clinical implication or need for different dosage regimen by genotypes is not established, yet.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators are trying to set up voriconazole (VCZ) therapeutic drug monitoring (TDM) & establish relationship with efficacy and safety in Korea. The investigators also want to propose the optimal dosage regimen for VCZ over different genotypes of CYP2C19 in the immunocompromised patients in Korea.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Observational Study of Plasma Voriconazole Concentration Measurement and Its Correlation With CYP2C19 Genotype in Korean Patients
    Study Start Date :
    May 1, 2008
    Anticipated Primary Completion Date :
    Apr 1, 2009
    Anticipated Study Completion Date :
    Apr 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Patients suspected of invasive fungal infection (proven or probable cases) with immunocompromised state (for example, during neutropenia, receiving HSCT) in Catholic Hematopoietic Stem Cell Transplantation [HSCT] Center in Seoul, Korea.

    Outcome Measures

    Primary Outcome Measures

    1. To regular setting of voriconazole TDM & establish relationship with efficacy and safety [Prospective]

    Secondary Outcome Measures

    1. To apply population pharmacokinetic-pharmacodynamic modeling and simulation technique on the clinical research of antifungal drugs. [Prospective]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Immunocompromised adults who are treated with voriconazole due to proven or probable invasive fungal infections
    Exclusion Criteria:

    • Patients who have been treated with other investigational drugs

    • Patients with liver dysfunction (aminotransferase level ≥ 5 times the upper limit of normal, bilirubin or alkaline phosphatase level > 3 times the upper limit of normal)

    • Patients with renal dysfunction (Cr level > 2.5 times the upper limit of normal)

    • Pregnant women

    • Patients younger than 15 years of age

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Mary's Hospital Seoul Korea, Republic of 150-713
    2 St. Mary's Hospital Seoul Korea, Republic of 150-713

    Sponsors and Collaborators

    • The Catholic University of Korea

    Investigators

    • Principal Investigator: Dong-Gun Lee, M.D., Ph.D., St. Mary's Hospital, The Catholic Univ. of Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00673348
    Other Study ID Numbers:
    • VCZ_TDM_Korea
    First Posted:
    May 7, 2008
    Last Update Posted:
    Jul 24, 2008
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    Mycoses
    Voriconazole
    Additional relevant MeSH terms:
    Mycoses
    Neutropenia

    Study Results

    No Results Posted as of Jul 24, 2008