Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06609226 | A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia | PHASE3 | RECRUITING | 480 | — | — | Jan 10, 2025 | Dec 30, 2030 | Mar 24, 2026 | 103 | United States, Canada +15 |
Measured as number of events.
Measured as number of adverse reactions.
| Arm | Type | Description |
|---|---|---|
| Participants greater than or equal to (≥) 12 years old with sickle cell disease | EXPERIMENTAL | Participants will receive an oral dose of Etavopivat A or C. |
| Participants ≥ 12 years old with sickle cell disease transfusion dependent | EXPERIMENTAL | Participants will receive an oral dose of Etavopivat A or C. |
| Participants ≥ 12 years old with transfusion-dependent thalassaemia | EXPERIMENTAL | Participants will receive an oral dose of Etavopivat A or C. |
| Participants ≥ 12 years old with non-transfusion dependent thalassaemia | EXPERIMENTAL | Participants will receive an oral dose of Etavopivat A or C. |
| Participants ≥ 2 years to less than (<) 12 years old with sickle cell disease | EXPERIMENTAL | Participants ≥ 12 years of age will receive an oral dose of Etavopivat A or C and participants \< 12 years of age will receive an oral dose of Etavopivat B. |
| Name | Type | Description |
|---|---|---|
| Etavopivat A | DRUG | Participants will receive an oral dose of Etavopivat A. |
| Etavopivat B | DRUG | Participants will receive an oral dose of Etavopivat B. |
| Etavopivat C | DRUG | Participants will receive an oral dose of Etavopivat C. |
Inclusion Criteria: * Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study. * Participant must have derived clinical benefit from treatment with etavopi...