Trial · NCT05568225
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Hematologic Improvement- Erythroid (HI-E) Response for >=8 Weeks Within 24 Weeks of Etavopivat Treatment | From Baseline to Week 24 | EES: All participants in the FAS who have completed the week 24 response visit and who have a baseline record of the primary endpoint. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hematologic Improvement-Erythroid (HI-E) Response for =>8 Weeks Within 16 and 48 Weeks of Etavopivat | 48 weeks | FAS: All participants who signed the informed consent and received at least 1 dose of etavopivat. Data for this outcome is not analyzed due to early study termination and have been excluded from planned analyses as prespecified in statistical analysis plan (SAP). | ||
| SECONDARY | Percentage of Participants With Hematologic Improvement- Erythroid (HI-E) Response for =>16 Weeks Within 24 and 48 Weeks of Etavopivat | 48 weeks | FAS: All participants who signed the informed consent and received at least 1 dose of etavopivat. Data for this outcome is not analyzed due to early study termination and have been excluded from planned analyses as prespecified in SAP. | ||
| SECONDARY | Number of All Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Related to Etavopivat | From baseline up to 48 weeks | Safety population includes all participants who received at least one dose of etavopivat (including partial dosing). | Events | NUMBER |
| SECONDARY | Number of Premature Discontinuations, Dose Interruptions, and Dose Reductions | Within 48 weeks | Safety population included all participants who receive at least one dose of etavopivat (including partial dosing). | Events | NUMBER |
| SECONDARY | Overall Response Rate | Up to 48 weeks | Data for this outcome is not analyzed due to early study termination and have been excluded from planned analyses as prespecified in SAP. | ||
| SECONDARY | Duration of Response | Up to 48 weeks | Data for this outcome is not analyzed due to early study termination and have been excluded from planned analyses as prespecified in SAP. | ||
| SECONDARY | Reduction in RBC Transfusions for >=8 Weeks in Participants With LTB or HTB at Study Entry | Up to 48 weeks | EES: All participants in the FAS who have completed the week 24 response visit and who have a baseline record of the primary endpoint. n (number analysed) = Participants with available data for a specified category. | Total RBS units | MEAN |
| SECONDARY | Percent Change From Baseline in RBC Transfusion Independence for =>8 Weeks in Participants With LTB or HTB at Study Entry | Up to 48 weeks | EES: All participants in the FAS who have completed the week 24 response visit and who have a baseline record of the primary endpoint. n (number analysed) = participants with available data for a specified category. | Percent change of total RBC units | MEAN |
| SECONDARY | Change From Baseline in Neutrophils and/or Platelets Counts | Baseline (week 0), week 48 | The Safety Set includes all participants who receive at least one dose of etavopivat (including partial dosing). Here, n (number analysed) = Participants with available data for a specified category. | 10^9 cells per liter | MEAN |
| SECONDARY | Decrease in Ferritin and Transferrin Saturation (TSAT) | Up to 48 weeks | Data for this outcome is not analyzed due to early study termination and have been excluded from planned analyses as prespecified in SAP. | ||
| SECONDARY | Decrease in Iron Chelation Therapy | up to 48 weeks | Data for this outcome is not analyzed due to early study termination and have been excluded from planned analyses as prespecified in SAP. | ||
| SECONDARY | Overall Survival | Within 48 weeks | Data for this outcome is not analyzed due to early study termination and have been excluded from planned analyses as prespecified in SAP. | ||
| SECONDARY | Etavopivat Plasma Concentrations | Weeks 1 and 4 pre-dose, post-dose 1, 2, 4, 6 hours.Week 2 and EOT (week 48):pre-dose, post-dose 1, 2 hours | The PK set includes all safety set participants who have at least one evaluable concentration for etavopivat at a scheduled PK time point after the start of dosing. Here, n (number analysed) = Participants with available data for a specified category. | ng/mL | MEAN |
| SECONDARY | RBC 2,3-diphosphoglycerate (2,3-DPG) and Adenosine Triphosphate (ATP) Levels Over Time | Within 48 weeks | Data for this outcome is not analyzed due to early study termination and have been excluded from planned analyses as prespecified in SAP. |
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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