Malaria Clinical Trial
— NOHARM-MTDOfficial title:
Optimizing Hydroxyurea Therapy in Children With Sickle Cell Anemia In Malaria Endemic Areas: The NOHARM Maximum Tolerated Dose (MTD) Study
Verified date | February 2020 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM) study is the first
placebo-controlled randomized clinical trial of hydroxyurea treatment in a malaria endemic
region. NOHARM has now achieved full enrollment; all children have completed the blinded
portion of the protocol and are in the open-label study treatment portion.
This extension study of maximum tolerated dose (MTD), addresses the next critical set of
questions about the optimal dosing and monitoring of hydroxyurea treatment for children with
SCA in low-resource settings. By providing guidance about optimal hydroxyurea treatment, the
NOHARM MTD Study will directly inform policies that can transform the health of African
children living with SCA.
Status | Completed |
Enrollment | 187 |
Est. completion date | January 28, 2020 |
Est. primary completion date | April 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Months to 72 Months |
Eligibility |
Inclusion Criteria: - Children with confirmed SCA who participated in the NOHARM study of hydroxyurea at the Mulago Hospital Sickle Cell Clinic (MHSCC), will be eligible for the MTD study after completing both 12-months of blinded study treatment and then an additional 12-months of open-label hydroxyurea for the second year of the study. - The age range for enrollment into NOHARM, which began in 2014, was 1-4 years. Therefore, the children who will be enrolled in the follow up MTD study will be 3-6 years of age. Exclusion Criteria: - Not willing to come for all scheduled clinical visits or accept randomization |
Country | Name | City | State |
---|---|---|---|
Uganda | Mulago Hospital Sickle Cell Clinic | Kampala |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Children's Hospital Medical Center, Cincinnati, Doris Duke Charitable Foundation, Makerere University, Mulago Hospital, Uganda |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of children with average hemoglobin =9.0 g/dL or average HbF =20% | Proportion of children who achieve either an average hemoglobin =9.0 g/dL or an average HbF =20% after 24 months on study drug | Over 24 month period on study drug | |
Secondary | Clinical malaria incidence | Clinical malaria is defined as a history of fever or measured axillary temperature =37.5 degrees, plus Plasmodium species on blood smear. | Over 24 month period on study drug | |
Secondary | Vaso-occlusive crises | SCA-related adverse events defined as: Pain event Dactylitis Acute chest syndrome |
Over 24 month period on study drug | |
Secondary | Incidence of severe adverse events (SAE) | Death, hospitalization >7 days, life-threatening event | Over 24 month period on study drug | |
Secondary | Incidence of hematologic toxicities | Hematologic toxicities are defined as: Hemoglobin (Hb) <4.0g/dL Hb <6.0g/dL AND absolute reticulocyte count (ARC) <100 x 10E9/L Hb <7.0g/dL AND ARC <80 x 10E9/L Platelets <80 x 10E9/L Absolute neutrophil count (ANC) <1.0 x 10E9/L |
Over 24 month period on study drug | |
Secondary | Cerebrovascular function | Transcranial Doppler blood vessel velocity to determine cerebrovascular function | At study treatment initiation then at 12 months and 24 months after study initiation | |
Secondary | Change in creatinine levels | Changes in creatinine level as a measure of renal function | Over 24 month period on study drug | |
Secondary | Change in cystatin C | Changes in cystatin C level as a measure of renal function | Over 24 month period on study drug | |
Secondary | Change in splenic function | Quantitative micronuclei [Howell Jolly bodies] measured by flow cytometry | Over 24 month period on study drug | |
Secondary | Change in height-for-age z-score | Change in height-for-age z-score | Over 24 month period on study drug | |
Secondary | Change in weight-for-age z-score | Change in weight-for-age z-score | Over 24 month period on study drug | |
Secondary | Change in weight-for-height z-score | Change in weight-for-height z-score | Over 24 month period on study drug |
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