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Generated: February 18, 2019

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CLINICAL TRIALS PROFILE FOR VORICONAZOLE

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Clinical Trials for Voriconazole

Trial ID Title Status Sponsor Phase Summary
NCT00001646 Voriconazole vs. Amphotericin B in the Treatment of Invasive Aspergillosis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Voriconazole

Condition Name

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

Condition MeSH for Voriconazole
Intervention Trials
Mycoses 51
Aspergillosis 28
Infection 18
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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 75
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 130
Industry 60
NIH 23
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Julphar
Daiichi Sankyo
Deloitte
Baxter
McKesson
Cantor Fitzgerald
Covington

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