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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00326157 |
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of graft versus host disease (GvHD), which are both high risk periods as far as severe fungal infection development is concerned.
Condition | Intervention | Phase |
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Fungus Diseases |
Drug: AmBisome |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Pilot Study on Safety of Administration of 3mg/kg/Day Three Times a Week Until Day 22 (21 Days After Transplantation Day) and 7 mg/kg Weekly From Day 29 to the End of Treatment (Day 50-8th Week) of AmBisome® in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem-Cell Transplantation |
Estimated Enrollment: | 40 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
AmBisome® will be administered for a duration of 8 weeks
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Drug: AmBisome
3mg/kg/day three times a week until day 22 (21 days after transplantation day) and 7 mg/kg weekly from day 29 to the end of treatment (day 50-8th Week) of AmBisome®, IV administration
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This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of GvHD, which are both high risk periods as far as severe fungal infection development is concerned.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients will be hospitalised prior to, and remain in the hospital for at least one day, after the first infusion.
Exclusion Criteria:
Responsible Party: | Gilead Sciences ( Luigi Antonio Picaro ) |
Study ID Numbers: | GS-IT-131-0151 |
Study First Received: | May 10, 2006 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00326157 History of Changes |
Health Authority: | Italy: The Italian Medicines Agency |
antifungal primary prophylaxis treatment allogeneic stem-cell transplantation antifungal primary prophylaxis treatment of high risk patients undergoing allogeneic stem-cell transplantation |
Abelcet Anti-Infective Agents, Local Anti-Bacterial Agents Amphotericin B Mycoses |
Clotrimazole Miconazole Antifungal Agents Tioconazole Liposomal amphotericin B |
Abelcet Amphotericin B Anti-Infective Agents Antiprotozoal Agents Clotrimazole Miconazole Tioconazole Liposomal amphotericin B Pharmacologic Actions |
Anti-Infective Agents, Local Anti-Bacterial Agents Mycoses Antiparasitic Agents Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Amebicides |