EUCTR2014-004184-21-Outside-EU/EEAActive, not recruitingNot Applicable
An open-label, intravenous to oral switch, multiple dose, multi-centre study to investigate the pharmacokinetics, safety and tolerability of Voriconazole in hospitalized children aged 2 to <12 years who require treatment for the prevention of systemic fungal infection
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Pfizer, Inc.
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Subjects (both male and female) from 2 to less than (<)12 years of age who require treatment for the prevention of systemic fungal infection, and who can tolerate being switched to oral therapy between Days 8 and 12.
- •2.Subjects who are expected to develop neutropenia (absolute neutrophil count [ANC < 500/microliter [µl]) lasting more than 10 days following chemotherapy for one of the following conditions:
- •a.Leukemia, including ALL, AML and relapsed leukemia
- •b.Lymphoma, including relapsed lymphoma
- •c.Aplastic anemia
- •d.As the preparative regimen for bone marrow or stem cell transplantation
- •3. Subjects who are anticipated to live for more than 3 months
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1.Subjects who are receiving and cannot discontinue the following drugs at least 24 hours prior to study start, or, if they need to commence any of the following during the study:
- •a.Terfenadine, pimozide, quinidine, astemizole and cisapride (due to the possibility of QTc prolongation)
- •b.Omeprazole (an inhibitor of cytochrome P450 2C19 [CYP2C19] which is known to increase plasma voriconazole levels)
- •c.Ergot alkaloids
- •2.Subjects who have received the following drugs within 14 days
- •prior to study entry:
- •Rifampicin, rifampin, rifabutin, carbamazepine, phenytoin, nevirapine and long acting barbiturates as these are inducers of hepatic enzymes and may result in undetectable levels of voriconazole.
- •a.Sirolimus as voriconazole is known to increase significantly sirolimus blood levels.
- •3.Subjects with any clinically significant abnormality following review of screening laboratory data other than that associated with their underlying disease.
- •4.Liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT] or total bilirubin) > 5 * upper limit of normal [ULN].
- •5.In subjects with clinically relevant hypokalemia potassium needs to be corrected before initiation of study treatment.
- •6.Subjects who are taking, or are likely to receive, any investigational drug other than chemotherapy, antiretroviral agents, and drugs used for the treatments of AIDS defining opportunistic infections, all of which are allowed.
- •7.Subjects with a history of hypersensitivity to or severe intolerance of azole antifungal agents.
- •8.Subjects who have already been entered into this protocol Subjects with moderate and severe renal impairment (i.e., calculated creatinine clearance <30 milliliter per minute (ml/min). Creatinine clearance will be calculated using the equation:
- •Creatinine Clearance (ml/min) = 0.55*height (centimeter [cm])/serum creatinine (milligram per deciliter [mg/dL])
- •9. Subjects who have prior or current evidence of cardiac
- •arrhythmia.
- •10. Females of child-bearing potential.
Investigators
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