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An Open-Label, Non-Controlled, Multicenter, Intravenous To Oral Switch, Phase 2 Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To Less Than 15 Years Who Are At High Risk For Systemic Fungal Infection


Phase 2
2 Years
15 Years
Not Enrolling
Both
Aspergillosis, Aspergilloma

Thank you

Trial Information

An Open-Label, Non-Controlled, Multicenter, Intravenous To Oral Switch, Phase 2 Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To Less Than 15 Years Who Are At High Risk For Systemic Fungal Infection


Inclusion Criteria:



- Male or female from 2 to <15 years of age.

- Require treatment for the prevention of systemic fungal infection.

- Expected to develop neutropenia (ANC <500 cells/uL) lasting more than 10 days
following chemotherapy.

- Anticipated to live for more than 3 months.

Exclusion Criteria:

- Evidence of any clinically significant liver or renal function or other abnormalities
such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.

- Documented bacterial or viral infection not responding to appropriate treatment.

- Hypersensitivity to or severe intolerance of azole antifungal agents.

- Receiving other azoles or drugs that is are prohibited in the voriconazole label or
associated.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state.

Outcome Time Frame:

Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

A1501096

NCT ID:

NCT01383993

Start Date:

September 2011

Completion Date:

May 2013

Related Keywords:

  • Aspergillosis, Aspergilloma
  • Open-Label
  • Pharmacokinetics
  • Intravenous to oral switch
  • Safety
  • Voriconazole
  • Immunocompromise
  • Children
  • High Risk For Systemic Fungal Infection
  • Aspergillosis
  • Mycoses

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