Trial · NCT05199766
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of the biological activity of voxelotor on the change of intra vascular hemolysis measured by decrease of plasma hemoglobin. | Change from Baseline at Week 48 | Change of Intravascular hemolysis, as defined by a ≥20% decrease of plasma Hemoglobin (µmol/l) |
| Secondary | Intra vascular hemolysis measured by plasma Heme | Week 0, Week 24, Week 48 | Absolute and relative (%) changes in plasma Hemoglobin (µmol/l) and free plasma Heme (µmol/l) |
| Secondary | Total hemoglobin mass (MHb) | Week 0, Week 24, Week 48 | Measurement of total hemoglobin mass based on the CO rebreathing technique (g of Hb / kg), or a stable evolution (i.e. decrease ≤ 10%) in patients initially under EPO therapy and who decreased or discontinued EPO during the study period. |
| Secondary | RBCs lifespan | Week 0, Week 24, Week 48 | RBC lifespan by measurement of alveolar CO (in days). |
| Secondary | Change of blood volumes (plasma volume (PV) and total blood volume (BV)) | Week 0, Week 24, Week 48 | Blood volumes by CO rebreathing method (Total blood volume (L), Plasma Volume (L) ) |
| Secondary | Change of red blood cell mass (RBCM) | Week 0, Week 24, Week 48 | RBC mass (g) |
| Secondary | Change of Total Mass of Hemoglobin | Week 0, Week 24, Week 48 | Total Mass of Hemoglobin (g of Hb) |
| Secondary | Change of blood viscosity | Week 0, Week 24, Week 48 | Blood viscosity (cP) |
| Secondary | Cerebral perfusion | Week 0, Week 24, Week 48 | Cerebral perfusion measured by MRI |
| Secondary | Change of cerebrovascular vaso-reactivity measured by transcranial Doppler | Week 0, Week 24, Week 48 | Transcranial Doppler (Breath holding test) |
| Secondary | Change of cerebrovascular vaso-reactivity measured by Near Infra Red Spectroscopy | Week 0, Week 24, Week 48 | Cerebral vaso-reactivity measured by Near Infra Red Spectroscopy |
| Secondary | Cognitive function (MoCA) | Week 0, Week 24, Week 48 | Cognitive performance measured by MoCA Improvement in the 6 minutes walk test on : Time spent under Sp02 88 and 90%, Borg Rating of Perceived Exertion (RPE), distance. |
| Secondary | Measurement of renal perfusion and amount of deoxyhemoglobin | Week 0, Week 24, Week 48 | Amount of deoxyhemoglobin by MRI |
| Secondary | Study of iron deposits in renal cortex | Week 0, Week 24, Week 48 | Iron deposits in renal cortex measured by MRI |
| Secondary | Measurement of Glomerular filtration rate | Week 0, Week 24, Week 48 | Estimation of glomerular filtration rate (CKD/EPI equation) |
| Secondary | Ability to decrease or stop erythropoietin in patients under EPO treatment | From Week 0 to Week48 | Concomitant treatment observation: decrease / interruption of EPO dose |
| Secondary | Incidence of Treatment-Adverse Events VOC, ACS and Priapism | From Week 0 to Week48 | Presence/Absence of adverse Events VOC, ACS, Priapism |
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.
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