Trial · NCT05199766
Hemolysis Related Complications in SCD. A Phase II Study With Voxelotor
NCT05199766, Phase 2, Unknown, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hemolysis Related Complications in SCD. A Phase II Study With Voxelotor. Trials, record NCT05199766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05199766
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hemolysis Related Complications in SCD. A Phase II Study With Voxelotor
- NCT number
- NCT05199766
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Sickle Cell Disease
- Interventions
- Voxelotor 1500 mg oral per day (GBT440) for 48 weeks in patients with sickle-cell disease
- First posted
- 2022-01-20
- Last updated
- 2023-09-21
- Other registries' IDs
- eudract:2020-005424-11
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 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 |
|---|---|
| 41603130 | 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/NCT05199766
GET https://conductscience.org/api/trials/v1/NCT05199766/registered