Trial · NCT03128515
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| Secondary | Change in weight-for-age z-score | Over 24 month period on study drug | Change in weight-for-age z-score |
| Secondary | Change in weight-for-height z-score | Over 24 month period on study drug | Change in weight-for-height z-score |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03128515/registered