Trial · NCT05949684
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period | Up to Week 96 | TD is defined as ≥ 3 red blood cells (RBC) units/16 weeks assessed by International Working Group (IWG) 2018. |
| Primary | Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 grams/deciliter (g/dL) in any continuous 16-week interval within the 48 week Treatment Period in the absence of transfusion | Up to Week 48 | |
| Secondary | Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion | Up to Week 96 | |
| Secondary | Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion | Up to Week 96 | |
| Secondary | Mean Hb change over fixed 24-week periods compared to the baseline Hb | Week 24, Week 48, Week 72, Week 96 | |
| Secondary | Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 96-week treatment period in the absence of transfusion | Up to Week 96 | |
| Secondary | Number of participants with TD by week 48 | Up to Week 48 | |
| Secondary | Time to TD (IWG 2018 defined as ≥ 3 RBC units/16 weeks) during any continuous 16-week interval until the end of study | Up to 5 years | |
| Secondary | Time from first Luspatercept dose to first RBC transfusion | Up to 5 years | |
| Secondary | Duration of mHI-E in participants with an increase from baseline in mean Hb values of ≥1.5g/dL in any continuous 16-week interval within the 48-week and 96-week treatment period in absence of transfusion | Up to Week 96 | mHI-E: median hematologic improvement in erythroid response |
| Secondary | Time from first dose to first day of response (increase in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 48-week and 96-week Treatment Period in the absence of transfusion) | Up to Week 96 | |
| Secondary | Number of participants with RBC transfusion independence over at least a consecutive 24-week period | Up to 5 years | |
| Secondary | Number of transfusions | Up to 5 years | |
| Secondary | Number of transfusions visits/units | Up to 5 years | |
| Secondary | Change from baseline in subscales of self-reported health-related quality-of-life (HRQoL) assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An) | Up to 5 years | |
| Secondary | Change from baseline in self-reported HRQoL assessed by the European quality of life questionnaire 5-dimension (EQ-5D-5L) | Up to 5 years | |
| Secondary | Number of participants with adverse events (AEs) | Up to 42 days post last dose | |
| Secondary | Number of participants with antidrug antibody (ADA) (positive or negative) | Up to Week 96 | |
| Secondary | Pharmacokinetics (PK): Serum concentration | Up to Week 96 | |
| Secondary | PK: Area under the plasma concentration time curve (AUC) | Up to Week 96 |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05949684/registered