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Last Updated: July 16, 2020

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CLINICAL TRIALS PROFILE FOR HYDROXYUREA

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505(b)(2) Clinical Trials for Hydroxyurea

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 Indication NCT04247750 Testing SIROLIMUS in Beta-thalassemia Transfusion Dependent Patients (THALA-RAP) Not yet recruiting Rare Partners srl Impresa Sociale Phase 2 2020-02-28 In β-thalassaemia and Sickle Cell Disease (SCD), a significant production of fetal haemoglobin (HbF) may reduce the severity of clinical course and reactivation of γ-globin gene expression in adulthood. HbF induction is one of the best strategies to ameliorate the characteristic symptoms of these diseases. Hydroxyurea (HU) is the only medication, approved by the US Food and Drug Administration, inducing HbF. However, treatments with HU induce sufficient HbF levels in only half of the patients, and side effects including leukopenia and neutropenia are frequently reported. Therefore, novel therapeutic inducers must be identified to develop a personalized treatment in β-thalassaemia and sickle cell anaemia. The availability of new treatments depends on drugs already approved for other indications, and on pharmacokinetics and pharmacovigilance already assessed. Rapamycin (as Sirolimus) is an immunosuppressant agent, approved by the FDA for acute rejection prevention in renal transplant recipients. The ability of this drug to induce γ-globin gene expression in erythroleukemia cell line and erythroid precursors cells (ErPCs) in ß-thalassaemia patients is already known. A clinical investigation on the effects of sirolimus in ß-Thalassaemia aims to evaluate several parameters related to red blood cell status and HbF levels and is a first step for the full clinical development in this new indication.
New Indication NCT04247750 Testing SIROLIMUS in Beta-thalassemia Transfusion Dependent Patients (THALA-RAP) Not yet recruiting Università degli Studi di Ferrara Phase 2 2020-02-28 In β-thalassaemia and Sickle Cell Disease (SCD), a significant production of fetal haemoglobin (HbF) may reduce the severity of clinical course and reactivation of γ-globin gene expression in adulthood. HbF induction is one of the best strategies to ameliorate the characteristic symptoms of these diseases. Hydroxyurea (HU) is the only medication, approved by the US Food and Drug Administration, inducing HbF. However, treatments with HU induce sufficient HbF levels in only half of the patients, and side effects including leukopenia and neutropenia are frequently reported. Therefore, novel therapeutic inducers must be identified to develop a personalized treatment in β-thalassaemia and sickle cell anaemia. The availability of new treatments depends on drugs already approved for other indications, and on pharmacokinetics and pharmacovigilance already assessed. Rapamycin (as Sirolimus) is an immunosuppressant agent, approved by the FDA for acute rejection prevention in renal transplant recipients. The ability of this drug to induce γ-globin gene expression in erythroleukemia cell line and erythroid precursors cells (ErPCs) in ß-thalassaemia patients is already known. A clinical investigation on the effects of sirolimus in ß-Thalassaemia aims to evaluate several parameters related to red blood cell status and HbF levels and is a first step for the full clinical development in this new indication.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Hydroxyurea

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000586 Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia (MSH) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1992-01-01 To assess the efficacy and safety of orally administered hydroxyurea in the treatment of painful crises in patients with sickle cell anemia.
NCT00000602 Pediatric Hydroxyurea in Sickle Cell Anemia (PED HUG) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1994-04-01 To determine whether hydroxyurea prevents the onset of chronic end organ damage in young children with sickle cell anemia.
NCT00000623 Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN) Completed National Heart, Lung, and Blood Institute (NHLBI) N/A 2000-07-01 The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.
NCT00000623 Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN) Completed Thalassemia Clinical Research Network N/A 2000-07-01 The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.
NCT00000623 Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN) Completed New England Research Institutes N/A 2000-07-01 The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.
NCT00000916 A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 This study compares the safety and effectiveness of continuing your current anti-HIV medications to that of adding or switching some of your anti-HIV medications. It will follow the effect of these medication changes, including the addition of hydroxyurea (HU), on long-term viral suppression. Other medications which may be added include didanosine (ddI) and/or stavudine (d4T). Patients receiving combination antiretroviral therapy with indinavir (IDV), zidovudine (ZDV)(or d4T) and lamivudine (3TC) show viral suppression for two years or more. Discontinuation of one or two of these drugs results in prompt loss of the viral suppression. Other studies show that addition of HU to some reverse transcriptase inhibitor treatments results in increased antiviral effects. This study will provide further information on the effect of adding HU to a treatment regimen with respect to long-term viral suppression.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hydroxyurea

Condition Name

Condition Name for Hydroxyurea
Intervention Trials
Sickle Cell Disease 49
Sickle Cell Anemia 30
Polycythemia Vera 18
HIV Infections 17
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Condition MeSH

Condition MeSH for Hydroxyurea
Intervention Trials
Anemia, Sickle Cell 90
Leukemia 30
Leukemia, Myeloid 30
Anemia 25
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Clinical Trial Locations for Hydroxyurea

Trials by Country

Trials by Country for Hydroxyurea
Location Trials
United States 665
Italy 62
Germany 37
France 33
Spain 26
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Trials by US State

Trials by US State for Hydroxyurea
Location Trials
Illinois 43
New York 40
Texas 39
North Carolina 37
Maryland 36
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Clinical Trial Progress for Hydroxyurea

Clinical Trial Phase

Clinical Trial Phase for Hydroxyurea
Clinical Trial Phase Trials
Phase 4 8
Phase 3 48
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Hydroxyurea
Clinical Trial Phase Trials
Completed 93
Recruiting 58
Not yet recruiting 27
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Clinical Trial Sponsors for Hydroxyurea

Sponsor Name

Sponsor Name for Hydroxyurea
Sponsor Trials
National Cancer Institute (NCI) 24
National Heart, Lung, and Blood Institute (NHLBI) 23
Novartis Pharmaceuticals 17
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Sponsor Type

Sponsor Type for Hydroxyurea
Sponsor Trials
Other 274
Industry 96
NIH 68
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