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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00289991 |
Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have has a Stem Cell Transplant. The success of the end point will be measures using evidence of Infection, drug compliance and survival.
Condition | Intervention | Phase |
---|---|---|
Antifungal Prophylaxis |
Drug: Itraconazole Drug: Vfend - voriconazole |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Open-Label, Comparative, Multi-Center Study Of Voriconazole Compared To Itraconazole For The Primary Prophylaxis Of Invasive Fungal Infection (IFI) With Allogeneic Hematopoietic Stem Cell Transplants (HSCT) |
Estimated Enrollment: | 500 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Itraconazole: Active Comparator |
Drug: Itraconazole
Prophylaxis
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Voriconazole: Experimental |
Drug: Vfend - voriconazole
Prophylaxis
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A1501073 |
Study First Received: | February 9, 2006 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00289991 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Mycoses Clotrimazole Miconazole Voriconazole |
Tioconazole Hydroxyitraconazole Itraconazole |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents |
Therapeutic Uses Antifungal Agents Pharmacologic Actions |