MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients
NCT02227797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2019-04-29
Summary
The primary purpose of this study is to identify the optimal dose of voriconazole, an anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level is one level that provides a good blood level (concentration) of voriconazole without too much toxicity.
Conditions
Interventions
- DRUG
-
Voriconazole
6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients
Sponsors & Collaborators
-
Masonic Cancer Center, University of Minnesota
lead OTHER
Principal Investigators
-
Angela Smith, M.D. · Masonic Cancer Center, University of Minnesota
-
Pui-Yang Iroh Tam, M.D. · Masonic Cancer Center, Univeristy of Minnesota
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-19
- Primary Completion
- 2017-09-08
- Completion
- 2019-03-01
Countries
- United States
Study Locations
More Related Trials
-
Voriconazole to Prevent Systemic Fungal Infections in Children
NCT00005912 ·Status: COMPLETED ·Phase: PHASE1
-
Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole
NCT00942773 ·Status: COMPLETED ·Phase: PHASE1
-
Voriconazole Pharmacokinetics in Children With Gastrointestinal Graft Versus Host Disease
NCT00792246 ·Status: COMPLETED ·Phase: PHASE1
-
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection
NCT01383993 ·Status: COMPLETED ·Phase: PHASE2
-
Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
NCT00143312 ·Status: COMPLETED ·Phase: PHASE4
-
Influence of CYP2C19 Genotype on Safety and Efficacy of Voriconazole in Pediatric Patients With Hematologic Malignancy
NCT04743544 ·Status: UNKNOWN
-
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children
NCT00174473 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Voriconazole Prophylaxis Against Aspergillosis in Lung Transplant Recipients
NCT00177827 ·Status: COMPLETED
-
A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant
NCT00606268 ·Status: COMPLETED ·Phase: PHASE1
-
An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
NCT00001757 ·Status: COMPLETED ·Phase: PHASE3
-
To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days
NCT00300677 ·Status: COMPLETED ·Phase: PHASE4
-
Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
NCT01503515 ·Status: COMPLETED ·Phase: PHASE3
-
The Influence of CYP2C19 Polymorphisms on the Safety and Efficacy of Voriconazole
NCT04547335 ·Status: UNKNOWN
-
Antifungal Use in Oncohematological Neutropenic Patients
NCT00386802 ·Status: COMPLETED ·Phase: PHASE4
-
An Observational Analysis of Voriconazole Therapeutic Drug Concentration Monitoring, Pharmacogenomics and Clinical Outcome Correlations in High-risk Hematology Patients
NCT01321372 ·Status: COMPLETED
-
Voriconazole as Prophylaxis for Liver Transplant Recipients
NCT00177788 ·Status: COMPLETED
-
Pharmacologic Optimization of Voriconazole
NCT00893555 ·Status: COMPLETED ·Phase: PHASE3
-
An Assessment of Voriconazole Pharmacokinetics and Pharmacogenetics in Liver Transplant Recipients - Pilot Study
NCT00371605 ·Status: TERMINATED
-
Efficacy of Prophylactic Itraconazole in High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation
NCT00336531 ·Status: COMPLETED ·Phase: PHASE4
-
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
NCT00739934 ·Status: COMPLETED ·Phase: PHASE2
-
Therapeutic Drug Monitoring of Voriconazole
NCT00890708 ·Status: COMPLETED ·Phase: NA
-
Voriconazole as Prophylactic Therapy in Lung Transplant Recipients
NCT00455364 ·Status: TERMINATED ·Phase: PHASE4
-
Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
NCT01417169 ·Status: UNKNOWN ·Phase: PHASE2
-
Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy
NCT00136968 ·Status: COMPLETED ·Phase: PHASE1
-
Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis
NCT00904995 ·Status: COMPLETED ·Phase: PHASE3