MycosesNCT00673348
Therapeutic Drug Monitoring (TDM) of Voriconazole and Correlation With CYP2C19 Genotype in Korean Populations
An observational study of Mycoses and Neutropenia, run by The Catholic University of Korea at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Mycoses, Neutropenia, Bone Marrow Transplantation
- How many people
- 40 participants
- Where
- 2 sitesSouth Korea
- Study dates
- May 2008to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Immunocompromised adults who are treated with voriconazole due to proven or probable invasive fungal infections
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Not yet recruiting
St. Mary's Hospital
Seoul, 150-713
Dong-Gun Lee, M.D., Ph.D., 82-2-3779-1114 ext. 1099, symonlee@catholic.ac.kr
Dong-Gun Lee, M.D., Ph.D.
- Recruiting
St. Mary's Hospital
Seoul, 150-713
Hae-Young Youn, Pharm D, 82-2-3779-1114 ext. 1216, baram@catholic.ac.kr
About this study
Official title: A Prospective Observational Study of Plasma Voriconazole Concentration Measurement and Its Correlation With CYP2C19 Genotype in Korean Patients
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.
Read the 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.
- Conditions
- Mycoses, Neutropenia, Bone Marrow Transplantation
- Keywords
- Mycoses, Voriconazole
- Medical subject headings
- Mycoses, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To regular setting of voriconazole TDM & establish relationship with efficacy and safety
Measured: Prospective
Secondary outcomes (1)
To apply population pharmacokinetic-pharmacodynamic modeling and simulation technique on the clinical research of antifungal drugs.
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2009 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MycosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Investigators
- Dong-Gun Lee, M.D., Ph.D., Principal investigator, St. Mary's Hospital, The Catholic Univ. of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673348
- Sponsor's protocol ID
- VCZ_TDM_Korea
- Status last verified
- Jun 2008
- First submitted
- 5 May 2008
- Last updated
- 24 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim SH, Yim DS, Choi SM, Kwon JC, Han S, Lee DG, Park C, Kwon EY, Park SH, Choi JH, Yoo JH. Voriconazole-related severe adverse events: clinical application of therapeutic drug monitoring in Korean patients. Int J Infect Dis. 2011 Nov;15(11):e753-8. doi: 10.1016/j.ijid.2011.06.004. Epub 2011 Aug 9.
PubMed 21831685
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Plasma Voriconazole Concentration Measurement and Its Correlation With CYP2C19 Genotype in Korean Patients
- ClinicalTrials.gov ID
- NCT00673348
- Acronym / sponsor ID
- VCZ_TDM_Korea
- Conditions
- Mycoses, Neutropenia, Bone Marrow Transplantation
- Keywords
- Mycoses, Voriconazole
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 7 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Immunocompromised adults who are treated with voriconazole due to proven or probable invasive fungal infections
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To regular setting of voriconazole TDM & establish relationship with efficacy and safety
Time frame: Prospective
1 secondary outcome
To apply population pharmacokinetic-pharmacodynamic modeling and simulation technique on the clinical research of antifungal drugs.
Time frame: Prospective
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2008.
- Derived from this study: PubMed 21831685Kim SH, Yim DS, Choi SM, Kwon JC, Han S, Lee DG, Park C, Kwon EY, Park SH, Choi JH, Yoo JH. Voriconazole-related severe adverse events: clinical application of therapeutic drug monitoring in Korean patients. Int J Infect Dis. 2011 Nov;15(11):e753-8. doi: 10.1016/j.ijid.2011.06.004. Epub 2011 Aug 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Gun Lee, M.D., Ph.D. principal investigator
St. Mary's Hospital, The Catholic Univ. of Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycoses and Neutropenia, run by The Catholic University of Korea at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Gun Lee, M.D., Ph.D. (82-2-3779-1114 ext. 1099, symonlee@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To regular setting of voriconazole TDM & establish relationship with efficacy and safety (time frame: Prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00673348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2008.