Trial · NCT06609226
A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia
NCT06609226, Phase 3, Recruiting, Novo Nordisk A/S
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia. Trials, record NCT06609226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06609226
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia
- NCT number
- NCT06609226
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 480 participants, estimated
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Sickle Cell Disease, Thalassemia
- Interventions
- Etavopivat A, Etavopivat B, Etavopivat C
- First posted
- 2024-09-24
- Last updated
- 2026-09-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of treatment emergent adverse events (TEAEs), reported for each indication and age group separately | Baseline (week 0 of FLORAL) up to end of study (up to week 316) | Measured as number of events. |
| Primary | Number of adverse reactions, reported for each indication and age group separately | Baseline (week 0 of FLORAL) up to end of study (up to week 316) | Measured as number of adverse reactions. |
| Secondary | Annualised vaso-occlusive crisis (VOC) rates, reported for each age group separately | Baseline (week 0 of FLORAL) up to end of treatment (up to week 312) | Measured as count. |
| Secondary | Change in VOCs, reported for each age group separately | Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312) | Measured as count. |
| Secondary | Change in hemoglobin (Hb) concentration, reported for each age group separately | Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312) | Measured as grams per deciliter (g/dL). |
| Secondary | Annualised number of hospitalisations, reported for each age group separately | Baseline (week 0 of FLORAL) up to end of treatment (up to week 312) | Measured as count. |
| Secondary | Average length of stay of hospitalisations, reported for each age group separately | Baseline (week 0 of FLORAL) up to end of treatment (up to week 312) | Measured as days. |
| Secondary | Change in Hb concentration | Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312) | Measured as g/dL. |
| Secondary | Number of red blood cell (RBC) units transfused, reported for each indication separately | Baseline (week 0 of FLORAL) up to end of treatment (up to week 312) | Measured as units. |
| Secondary | Change in RBC units transfused, reported for each indication separately | Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312) | Measured as units. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06609226
GET https://conductscience.org/api/trials/v1/NCT06609226/registered