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Last Updated: May 25, 2022

CLINICAL TRIALS PROFILE FOR ITRACONAZOLE


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505(b)(2) Clinical Trials for Itraconazole

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 NCT02372357 ↗ A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Institutul Clinic Fundeni 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 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 Itraconazole

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000639 ↗ A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis Completed Washington University School of Medicine N/A 1969-12-31 To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
NCT00000639 ↗ A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
NCT00000975 ↗ A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS Completed Janssen Pharmaceuticals Phase 2 1969-12-31 To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Itraconazole

Condition Name

Condition Name for Itraconazole
Intervention Trials
Healthy 62
Healthy Volunteers 20
Healthy Participants 17
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Condition MeSH

Condition MeSH for Itraconazole
Intervention Trials
Mycoses 19
Infections 17
Infection 17
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Clinical Trial Locations for Itraconazole

Trials by Country

Trials by Country for Itraconazole
Location Trials
United States 325
Germany 29
United Kingdom 29
China 28
Canada 22
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Trials by US State

Trials by US State for Itraconazole
Location Trials
Texas 47
California 33
Florida 18
Kansas 18
Arizona 15
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Clinical Trial Progress for Itraconazole

Clinical Trial Phase

Clinical Trial Phase for Itraconazole
Clinical Trial Phase Trials
Phase 4 26
Phase 3 18
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Itraconazole
Clinical Trial Phase Trials
Completed 245
Recruiting 27
Not yet recruiting 15
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Clinical Trial Sponsors for Itraconazole

Sponsor Name

Sponsor Name for Itraconazole
Sponsor Trials
Boehringer Ingelheim 17
Pfizer 16
AstraZeneca 12
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Sponsor Type

Sponsor Type for Itraconazole
Sponsor Trials
Industry 262
Other 167
NIH 18
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