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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 March 2023 |
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Main ID: |
NCT02149537 |
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Date of registration:
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24/03/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Risk Clinical Stratification of Sickle Cell Disease in Nigeria, Assessment of Efficacy/Safety of Hydroxyurea Treatment
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Scientific title:
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Risk Stratification for Clinical Severity of Sickle Cell Disease in Nigeria and Assessment of Efficacy and Safety During Treatment With Hydroxyurea |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02149537 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Titilola S Akingbola, MBBS, FWACP |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ibadan College of Medicine, Nigeria |
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Name:
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Bamidele O Tayo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Loyola University Chicago |
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Name:
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Richard S Cooper, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Loyola University Chicago |
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Name:
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Lewis Hsu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Illinois at Chicago |
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Name:
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Victor R Gordeuk, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Illinois at Chicago |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age >= 18 years
- HemoglobinSS (HbSS) or beta-zero (B0) thalassemia genotype
- Hemoglobin concentration >4.5 g/dL at steady state and time of enrollment
- Absolute neutrophil count >1,500/mircoliter
- Platelet count >95,000/microliter
- Serum creatinine <1.2 mg/dL
- Alanine transaminase less than two times the upper limit of normal
Exclusion Criteria:
- HIVpositive
- Hepatitis B and/or C positive
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sickle Cell Anemia
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Sickle Cell Disease
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Intervention(s)
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Drug: hydroxyurea
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Primary Outcome(s)
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Cytopenia
[Time Frame: every 2 weeks during a period of 6 months]
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Secondary Outcome(s)
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Development of infection evaluated by a physician at the point of care
[Time Frame: every 2 weeks for period of 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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