Realizing effectiveness across continents with hydroxyurea: Enrollment and baseline characteristics of the multicenter REACH study in Sub-Saharan Africa
| Autor: | McGann, PT, Williams, TN, Olupot-Olupot, P, Tomlinson, GA, Lane, A, Luís Reis da Fonseca, J, Kitenge, R, Mochamah, G, Wabwire, H, Stuber, S, Howard, TA, McElhinney, K, Aygun, B, Latham, T, Santos, B, Tshilolo, L, Ware, RE, REACH Investigators |
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| Přispěvatelé: | Investigators, REACH |
| Rok vydání: | 2018 |
| Předmět: |
Male
CHILDREN REACH Investigators Comorbidity Global Health DISEASE BABY HUG 0302 clinical medicine TRANSCRANIAL DOPPLER Ischemia Hydroxyurea Prospective Studies Child Stroke RISK Ethics committee Hematology Gene deletion Combined Modality Therapy Sickle cell anemia Child Preschool 030220 oncology & carcinogenesis Baseline characteristics TRIAL Female Life Sciences & Biomedicine Sub saharan SICKLE-CELL-ANEMIA Immunology Anemia Sickle Cell 1102 Cardiovascular Medicine And Haematology Article 03 medical and health sciences alpha-Thalassemia medicine Humans Blood Transfusion Dosing Africa South of the Sahara Science & Technology business.industry medicine.disease Malaria LOW-DOSE HYDROXYUREA Glucosephosphate Dehydrogenase Deficiency Feasibility Studies business 030215 immunology Demography |
| Zdroj: | American Journal of Hematology. 93:537-545 |
| ISSN: | 0361-8609 0196-6731 |
| Popis: | Despite its well-described safety and efficacy in the treatment of sickle cell anemia (SCA) in high-income settings, hydroxyurea remains largely unavailable in sub-Saharan Africa, where more than 75% of annual SCA births occur and many comorbidities exist. Realizing Effectiveness Across Continents with Hydroxyurea (REACH, ClinicalTrials.gov NCT01966731) is a prospective, Phase I/II open-label trial of hydroxyurea designed to evaluate the feasibility, safety, and benefits of hydroxyurea treatment for children with SCA in four sub-Saharan African countries. Following comprehensive training of local research teams, REACH was approved by local Ethics Committees and achieved full enrollment ahead of projections with 635 participants enrolled over a 30-month period, despite half of families living >12 km from their clinical site. At enrollment, study participants (age 5.4 ± 2.4 years) had substantial morbidity, including a history of vaso-occlusive pain (98%), transfusion (68%), malaria (85%), and stroke (6%). Significant differences in laboratory characteristics were noted across sites, with lower hemoglobin concentrations (P |
| Databáze: | OpenAIRE |
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