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Last Updated: December 6, 2019

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CLINICAL TRIALS PROFILE FOR VORICONAZOLE

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505(b)(2) Clinical Trials for Voriconazole

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT00421187 Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics Terminated Gilead Sciences Phase 4 2007-03-01 Administration of a single high dose (10 mg/kg) of AmBisome® no later than 72 hours after ARNF onset followed by two 5 mg/kg doses on days 2 and 5 may provide sustained tissue levels of amphotericin B that are as mycologically effective as those provided after administering the standard daily dose of 3 mg/kg/day. The new dosing regimen is anticipated to be equally clinically effective compared with the standard AmBisome® regimen when given for the duration of neutropenic fever in patients with ARNF. In addition, the degree and incidence of nephrotoxicity are predicted to be lower with the 3 sequential dose regimen compared to daily dosing with 3 mg/kg because of the lower cumulative dosage (20 mg/kg versus 42 mg/kg, respectively), which is 1 contributing factor for the development of acute renal failure. Furthermore, the lower cumulative dose may be a cost-effective strategy for the treatment of patients with ARNF.
New Dosage NCT02372357 A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Institutul Clinic Fundeni Bucharest Phase 4 2012-02-01 A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage NCT02372357 A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Universitaire Ziekenhuizen Leuven Phase 4 2012-02-01 A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Voriconazole

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001646 Voriconazole vs. Amphotericin B in the Treatment of Invasive Aspergillosis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1997-08-01 Invasive aspergillosis is a fungal disease which is increasing in incidence with the increase in immunocompromised persons in our population. Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at the highest risk for acute aspergillosis. Patients undergoing bone marrow transplantation, receiving prolonged corticosteroid or other immunosuppressive therapies, and persons with HIV infection and AIDS are also at risk. Even with antifungal therapy, aspergillosis in its acute invasive forms has a high mortality. In bone marrow transplantation patients and in those whose infection involves the brain, this mortality is greater than 90%. Amphotericin B in its conventional form, is the current standard treatment for this disease. Response to therapy with amphotericin B usually ranges between 20-60% in most studies. The higher response rates are usually seen in those patients who can tolerate this agent for at least 14 days. Because of its nephrotoxicity and other adverse effects, alternatives to conventional amphotericin B have been sought. These currently include liposomal forms of amphotericin B and itraconazole. Although these forms show a decrease in adverse effects, the efficacy of these drugs has not been shown to be equivalent to conventional amphotericin B. Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US. This azole has been shown active against Aspergillus spp. in vitro, and in animal models and early human trials to be effective against aspergillosis. It has been shown to be well-tolerated and is available in an intravenous and oral formulation. This study will evaluate the efficacy, safety, and toleration of voriconazole compared to conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis in immunocompromised patients. Patients will be randomized to open-labelled therapy with voriconazole or amphotericin B in a one-to-one ratio.
NCT00001757 An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1997-11-01 Invasive fungal infections are often life-threatening in persons with immunocompromise. Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at high risk for these infections. Patients undergoing bone marrow transplantation, receiving prolonged corticosteroid or other immunosuppressive therapies, and persons with HIV infection and AIDS are also at risk. With the use of currently approved antifungal therapy, many of these infections may still be associated with a high mortality. Amphotericin B in its conventional form, is the current standard treatment for most life-threatening fungal infections. Because of its nephrotoxicity and other adverse effects, alternatives to conventional amphotericin B have been sought. Alternated agents include three lipid formulations of amphotericin B, fluconazole, itraconazole. Although all of these agents are associated with a decrease in adverse effects, their efficacy in most life-threatening fungal infections has not been shown to be equivalent to conventional amphotericin B. Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US. This azole has been shown active against many fungal pathogens in vitro. In animal models and early human trials this new agent has been shown to be effective against aspergillosis. It has been shown to be well-tolerated and is available in an intravenous and oral formulation. This is a non-comparative, open label study to evaluate the efficacy, safety and toleration of voriconazole in the treatment of invasive fungal infections. This agent will be used as primary therapy in those fungal infections in which no antifungal agent is currently approved or in patients unable to tolerate the approved agent. Voriconazole will also be used as a secondary treatment in those patients who have failed therapy with the primary approved agent or are unable to tolerate that agent or have unacceptable toxicity.
NCT00001810 An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections Completed National Cancer Institute (NCI) Phase 3 1999-04-01 The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy; and in the secondary treatment of systemic or invasive fungal infections in patients failing or intolerant to treatment with approved systemic antifungal agents. This trial is a Phase II multicenter, open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections. Enrollment is targeted for 150 patients to be recruited from multiple centers. The patient population will consist of patients with proven, deeply invasive fungal infection for which there is no licensed therapy or if the patient is failing or intolerant to treatment with approved systemic antifungal agents. Voriconazole will be administered initially by a loading dose of 6 mg/kg q12 hours for the first two doses followed by 4 mg/kg q12 hours. Efficacy will be evaluated by clinical, radiological and microbiological response.
NCT00001940 Voriconazole to Treat Fungal Infections Completed National Cancer Institute (NCI) Phase 3 1999-12-01 Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug had been studied in more than 1,900 healthy volunteers or patients with fungal infections. This study will test extended use of voriconazole in patients with serious fungal infections for which there are no approved therapies, and in patients who did not improve with or could not tolerate standard therapy. It will evaluate the drug's safety, effectiveness, and toleration in these patients. Patients previous enrolled in protocol 99-C-0094 who improved with voriconazole treatment are eligible for this study. Before beginning treatment, patients will have a physical examination, including blood and urine tests, and an eye examination. They may also have X-ray or CT imaging. Voriconazole will then be given twice a day either by infusion into a vein or by tablets taken by mouth for up to 12 weeks. Patients will be examined at weeks 4, 8 and 12 of the study and one week after treatment stops. Blood and urine samples will be collected at each visit. An eye examination will be done at the end of the treatment period and at other visits if vision problems develop. Voriconazole is active against fungal infections and may produce fewer side effects than standard therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Voriconazole

Condition Name

Condition Name for Voriconazole
Intervention Trials
Aspergillosis 13
Fungal Infection 12
Leukemia 7
Mycoses 7
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Condition MeSH

Condition MeSH for Voriconazole
Intervention Trials
Mycoses 51
Aspergillosis 28
Infection 18
Communicable Diseases 11
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Clinical Trial Locations for Voriconazole

Trials by Country

Trials by Country for Voriconazole
Location Trials
United States 217
Canada 21
India 20
France 17
Spain 16
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Trials by US State

Trials by US State for Voriconazole
Location Trials
Texas 18
California 18
Maryland 17
Pennsylvania 11
Ohio 11
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Clinical Trial Progress for Voriconazole

Clinical Trial Phase

Clinical Trial Phase for Voriconazole
Clinical Trial Phase Trials
Phase 4 27
Phase 3 28
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Voriconazole
Clinical Trial Phase Trials
Completed 76
Recruiting 20
Terminated 11
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Clinical Trial Sponsors for Voriconazole

Sponsor Name

Sponsor Name for Voriconazole
Sponsor Trials
Pfizer 33
National Cancer Institute (NCI) 10
University of California, San Francisco 5
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Sponsor Type

Sponsor Type for Voriconazole
Sponsor Trials
Other 134
Industry 61
NIH 23
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