Last reviewed · How we verify
NCT03715972: CVR
Cerebrovascular Reserve and White Matter Disease in Patients with Chronic Anemia
trial testing Hydroxyurea in Thalassemia in 165 participants. Completed in 31 December 2022.
31 December 2022
Quick facts
| Lead sponsor | Children's Hospital Los Angeles |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 165 |
| Start date | 15 July 2018 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hydroxyurea — full drug profile →
- Acetazolamide (ACETAZOLAMIDE) — full drug profile →
Conditions studied
- Thalassemia — all drugs for Thalassemia →
- Sickle Cell Disease — all drugs for Sickle Cell Disease →
- Healthy Controls — all drugs for Healthy Controls →
Sponsor
Children's Hospital Los Angeles
Who can join
7 and older, any sex, with Thalassemia or Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is primarily an observational trial in patients with chronic anemia syndromes (sickle cell disease and thalassemia) and control subjects. The key purpose is to understand how brain blood flow reserve (the ability of the brain to increase its flow in response to stress) is altered in patients with chronic anemia. Since this parameter may depend on anemia severity, we will perform the MRI monitoring prior to and following clinically indicated transfusions in a subset of patients. Most patients will already be prescribed hydroxyurea as part of their standard of care. Since hydroxyurea could impact brain blood flow, there is also a small pilot study (20 patients, nonrandomized, open label) where MRI imaging will be performed prior to and following administration of hydroxyurea up to maximum tolerated dose. The study will enroll 90 adult subjects with transfusion independent sickle cell disease (70 SS, 10 SC, 10 Sβ0) and 60 patients with transfusion-dependent sickle cell disease. It will also include 10 transfusion independent thalassemia patients and 20 transfusion dependent thalassemia patients as well as 40 control subjects recruited from first degree relatives of the sickle cell disease population. All eligible subjects will be asked to provide informed consent before participating in the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03715972
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Hydroxyurea
Trials testing the same drug.
- NCT06930352 — Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for S · Phase 2 · not yet recruiting
- NCT06871410 — Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
- NCT06526117 — Stroke Prevention in Nigeria 2 Trial · Phase 4 · recruiting
- NCT06456346 — Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007) · Phase 3 · recruiting
- NCT05285917 — Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa · Phase 3 · recruiting
Other recruiting trials for Thalassemia
Currently open trials in the same condition.
- NCT06609226 — A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia · Phase 3 · recruiting
- NCT07064941 — Effect of Exercise on Body Composition and Bone Health in Patients With Thalassemia · NA · recruiting
- NCT06800495 — Development of THALEA Kit and Its Impact on Knowledge, Attitude, and Intention for Premarital Thalassemia Screening · NA · active not recruiting
- NCT06313398 — Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling · EARLY_PHASE1 · recruiting
- NCT05736419 — A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an · Phase 2 · recruiting
Other Children's Hospital Los Angeles trials
Trials by the same sponsor.
- NCT07064824 — Adaptive Cell Phone Support (ACPS) · NA · not yet recruiting
- NCT07508436 — Crisis Interventions for Pediatric Providers - Autism Version · NA · not yet recruiting
- NCT06934655 — Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth · Phase 3 · not yet recruiting
- NCT07427862 — Virtual Reality (VR) for Interventional Radiology (IR) Procedures · recruiting
- NCT07213908 — Comparing Two School-Based Sleep Health Interventions To Promote Sleep Quality in Youth · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03715972 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Los Angeles
- Last refreshed: 30 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03715972.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing