Invasive Fungal InfectionNCT01148160
Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic Malignancy
An observational study of Invasive Fungal Infection, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Invasive Fungal Infection
- What is being tested?
- voriconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Apr 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Who may be able to join
- male or female ≥ 15 years of age
- immunocompromised patients with hematologic disorders
- patients received voriconazole due to treat proven, probable invasive (pulmonary) aspergillosis
Who cannot join
- severe hepatic dysfunction (t.bil, AST, ALT, ALP > 5 x upper normal limit)
- who experienced hypersensitivity to azoles
- pregnant women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736
About this study
Official title: The Correlation of Voriconazole Trough Plasma Levels With Genetic Polymorphism, Efficacy, and Safety Outcomes in Hematologic Malignancy Patients With Invasive Pulmonary Aspergillosis
Multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes.
Voriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by CYP2C19. The polymorphisms account for a relatively large portion of inter-individual variance observed in voriconazole plasma concentrations.
Read more
However, there are limited data on the relationships between voriconazole blood levels and clinical outcomes or safety in Asian populations.
The purpose of this study is to investigate the relationships of voriconazole blood levels with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with invasive pulmonary aspergillosis.
Read the detailed description
The investigators are trying to establish that routine clinical practice for voriconazole therapeutic drug monitoring can improve the efficacy and safety outcomes.
In Korean patients with hematologic malignancy, the investigators also want to propose the optimal dosing guideline of voriconazole with different genetic polymorphisms.
- Conditions
- Invasive Fungal Infection
- Being tested
- voriconazole
- Keywords
- voriconazole, invasive pulmonary aspergillosis, hematologic malignancy, therapeutic drug monitoring, genetic polymorphism, efficacy, safety
- Medical subject headings
- Invasive Fungal Infections, Invasive Pulmonary Aspergillosis, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voriconazoleDrug
intravenous, oral administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea Receives: Drug: voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful outcome at 12 weeks after voriconazole use
Successful outcome = complete response + partial response Unsuccessful outcome = stable disease + failure of therapy + indeterminate response
Measured: 12 weeks
Secondary outcomes (5)
IFI (invasive fungal infection)-related mortality at 12 weeks
IFI (invasive fungal infection)-related mortality at 12 weeks
Measured: 12 weeks
Successful outcomes at various time points
Successful outcomes at 1 week,2 weeks,4 weeks, and 8 weeks after voriconazole use
Measured: 1 week, 2 weeks, 4 weeks, and 8 weeks
Non-IFI (invasive fungal infection)-related mortality at 12 weeks
Non-IFI (invasive fungal infection)-related mortality at 12 weeks
Measured: 12 weeks
breakthrough IFI
breakthrough IFI
Measured: 12 weeks
Adverse drug reactions
Adverse drug reactions (liver function test impairment, visual disturbance, hallucination, photosensitive rash, renal impairment)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Han Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148160
- Sponsor's protocol ID
- VCZ-IPA-HEM-2010
- Status last verified
- Apr 2014
- First submitted
- 18 Jun 2010
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Voriconazole Trough Plasma Levels With Genetic Polymorphism, Efficacy, and Safety Outcomes in Hematologic Malignancy Patients With Invasive Pulmonary Aspergillosis
- ClinicalTrials.gov ID
- NCT01148160
- Acronym / sponsor ID
- VCZ-IPA-HEM-2010
- Conditions
- Invasive Fungal Infection
- Keywords
- voriconazole, invasive pulmonary aspergillosis, hematologic malignancy, therapeutic drug monitoring, genetic polymorphism, efficacy, safety
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Jun 2010 (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.
Multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes.
Voriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by CYP2C19. The polymorphisms account for a relatively large portion of inter-individual variance observed in voriconazole plasma concentrations.
However, there are limited data on the relationships between voriconazole blood levels and clinical outcomes or safety in Asian populations.
The purpose of this study is to investigate the relationships of voriconazole blood levels with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with invasive pulmonary aspergillosis.
Detailed description
The investigators are trying to establish that routine clinical practice for voriconazole therapeutic drug monitoring can improve the efficacy and safety outcomes.
In Korean patients with hematologic malignancy, the investigators also want to propose the optimal dosing guideline of voriconazole with different genetic polymorphisms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: voriconazolePatients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Key inclusion criteria (3 listed)
- male or female ≥ 15 years of age
- immunocompromised patients with hematologic disorders
- patients received voriconazole due to treat proven, probable invasive (pulmonary) aspergillosis
Key exclusion criteria (3 listed)
- severe hepatic dysfunction (t.bil, AST, ALT, ALP > 5 x upper normal limit)
- who experienced hypersensitivity to azoles
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| voriconazoleintravenous, oral administration | Drug | 1 |
Primary outcome
Successful outcome at 12 weeks after voriconazole use
Time frame: 12 weeks
Successful outcome = complete response + partial response Unsuccessful outcome = stable disease + failure of therapy + indeterminate response
5 secondary outcomes
IFI (invasive fungal infection)-related mortality at 12 weeks
Time frame: 12 weeks
Successful outcomes at various time points
Time frame: 1 week, 2 weeks, 4 weeks, and 8 weeks
Non-IFI (invasive fungal infection)-related mortality at 12 weeks
Time frame: 12 weeks
breakthrough IFI
Time frame: 12 weeks
Adverse drug reactions
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infection, run by Asan Medical Center at 1 site 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful outcome at 12 weeks after voriconazole use (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2014; AzTrials last refreshed its copy on 8 Nov 2026.