Trial · NCT03128515
Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas
NCT03128515, Phase 3, Completed, Indiana University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas. Trials, record NCT03128515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03128515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas
- NCT number
- NCT03128515
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 187 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Sickle Cell Anemia, Sickle Cell Disease, Malaria
- Interventions
- Hydroxyurea
- First posted
- 2017-04-25
- Last updated
- 2020-02-20
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of children with average hemoglobin ≥9.0 g/dL or average HbF ≥20% | Over 24 month period on study drug | Proportion of children who achieve either an average hemoglobin ≥9.0 g/dL or an average HbF ≥20% after 24 months on study drug |
| Secondary | Clinical malaria incidence | Over 24 month period on study drug | Clinical malaria is defined as a history of fever or measured axillary temperature ≥37.5 degrees, plus Plasmodium species on blood smear. |
| Secondary | Vaso-occlusive crises | Over 24 month period on study drug | SCA-related adverse events defined as: * Pain event * Dactylitis * Acute chest syndrome |
| Secondary | Incidence of severe adverse events (SAE) | Over 24 month period on study drug | Death, hospitalization \>7 days, life-threatening event |
| Secondary | Incidence of hematologic toxicities | Over 24 month period on study drug | 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 |
| Secondary | Cerebrovascular function | At study treatment initiation then at 12 months and 24 months after study initiation | Transcranial Doppler blood vessel velocity to determine cerebrovascular function |
| Secondary | Change in creatinine levels | Over 24 month period on study drug | Changes in creatinine level as a measure of renal function |
| Secondary | Change in cystatin C | Over 24 month period on study drug | Changes in cystatin C level as a measure of renal function |
| Secondary | Change in splenic function | Over 24 month period on study drug | Quantitative micronuclei \[Howell Jolly bodies\] measured by flow cytometry |
| Secondary | Change in height-for-age z-score | Over 24 month period on study drug | Change in height-for-age z-score |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32579813 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03128515
GET https://conductscience.org/api/trials/v1/NCT03128515/registered