NCT02227797

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

January 19, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

2.6 years

First QC Date

August 26, 2014

Last Update Submit

April 26, 2019

Conditions

Fungal Infection

Keywords

stem cell transplanthematopoietic stem cell transplantfungal infectionvoriconazolepediatric

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups

    Seven days after starting voriconazole

Secondary Outcomes (3)

  • Correlation of initial dose of voriconazole with voriconazole blood concentration in 3 different pediatric age groups

    After starting voriconazole: Day 5, between Days 12-15, between Days 19-22

  • Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes

    After starting voriconazole: Twice a week Days 1-30 and 1 week after the last dose of voriconazole ~ Day 35-42

  • Incidence of fungal infection

    6-month period after transplant

Study Arms (1)

Voriconazole

EXPERIMENTAL
Drug: Voriconazole

Interventions

VoriconazoleDRUG

6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients

Voriconazole

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st or subsequent)
  • Age ≤ 21 years
  • Adequate organ function within 14 days of enrollment, i.e. Creatinine: \< 1.5 x ULN and Hepatic: ALT, AST and total bilirubin \< 3 x ULN
  • Requires voriconazole to prevent or treat invasive fungal infection after undergoing stem cell transplantation

You may not qualify if:

  • Has received voriconazole within 5 days prior to starting study therapy
  • History of hypersensitivity or severe intolerance to azoles
  • History, or current evidence, of cardiac arrhythmias defined as QTc ≥ 480 mm/sec
  • Receiving the following drugs and cannot be discontinued at least 24 hours before starting therapy: pimozide, quinidine, astemizole, ergot alkaloids.
  • Received one or more of the following drugs within 14 days prior to starting study, as they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin, carbamazepine, phenytoin, nevirapine, long-acting barbiturates.
  • Received sirolimus within the 14 days prior to starting study as voriconazole is a potent inhibitor of sirolimus metabolism
  • Receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Takahashi T, Jaber MM, Smith AR, Jacobson PA, Fisher J, Kirstein MN. Predictive Value of C-Reactive Protein and Albumin for Temporal Within-Individual Pharmacokinetic Variability of Voriconazole in Pediatric Patients Undergoing Hematopoietic Cell Transplantation. J Clin Pharmacol. 2022 Jul;62(7):855-862. doi: 10.1002/jcph.2024. Epub 2022 Feb 19.

    PMID: 34970774DERIVED

MeSH Terms

Conditions

Mycoses

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Angela Smith, M.D.

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Pui-Yang Iroh Tam, M.D.

    Masonic Cancer Center, Univeristy of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 28, 2014

Study Start

January 19, 2015

Primary Completion

September 8, 2017

Study Completion

March 1, 2019

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

US(1)