A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents

Verified by: Pfizer, August 2010
First Received: November 9, 2007 | Last Updated: August 2, 2010 | Phase: Phase 1/Phase 2 | Start Date: June 2008
Overall Status: Completed | Estimated Enrollment: 26
  • …
  • Tell a FriendPrint

This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents...

Brief Summary

Official Title: “An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Adolescents Aged 12 To <17 Years Who Are At High Risk For Systemic Fungal Infection”

This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
  • Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

  • Drug: Voriconazole
    • Voriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1

Outcome Measures for this Clinical Trial

Primary Measures

  • Pharmacokinetic parameters of voriconazole in adolescents compared to historical adult data.
    • Time Frame: 14 to 30 days
      Safety Issue?: No

Secondary Measures

  • Safety and tolerability of voriconazole in adolescents
    • Time Frame: 14 to 30 days
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Subjects who are expected to develop neutropenia following chemotherapy.
  • Subjects who require treatment for the prevention of systemic fungal infection.

Exclusion Criteria:

  • Subjects with a history of severe intolerance of azole antifungal agents.
  • Subjects with documented bacterial or viral infection at the time of study entry who are not responding to appropriate treatment against the infection.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00556998

Study ID Number: A1501081

ClinicalTrials.gov Identifier: NCT00556998

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00556998