Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03682536 · OUTCOME

Mean Hemoglobin Change Over 24 Weeks

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve · Source last updated 2024-11-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
g/dL
Interval / dispersion
Standard Deviation
Time frame
Week 1 through Week 24

What was measured

Mean hemoglobin (Hgb) change over the 24-week period of Week 1 through Week 24 compared to baseline. After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated. 4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being \< 14 days after the previous transfusion.

Analysis population: ITT Population (all randomized participants regardless of whether or not the participant received treatment) with baseline measurements.

Groups in this outcome

Luspatercept

Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.

Epoetin Alfa

Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Luspatercept181
Epoetin Alfa176

Reported measurements

Source class 1
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept2.01.14Not reportedNot reportedNot reported
Epoetin Alfa1.51.12Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.14
        value
        2.0
      2. group Id
        OG001
        spread
        1.12
        value
        1.5
denoms
  1. counts
    1. group Id
      OG000
      value
      181
    2. group Id
      OG001
      value
      176
    units
    Participants
description
Mean hemoglobin (Hgb) change over the 24-week period of Week 1 through Week 24 compared to baseline. After applying below 14/3-day rule, the baseline Hgb value is defined as the lowest Hgb value from the central, local laboratory, or pre transfusion Hgb from transfusion records that is within 56 days on or prior to the first dose of treatment, or randomization date if participants were not treated. 4/3-day rule: only Hgb values that are at least 14 days after a transfusion may be used unless there is another transfusion within 3 days after the Hgb assessment. If this occurs, that Hgb value will be used despite being \< 14 days after the previous transfusion.
dispersion Type
Standard Deviation
groups
  1. description
    Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
    id
    OG000
    title
    Luspatercept
  2. description
    Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
    id
    OG001
    title
    Epoetin Alfa
param Type
MEAN
population Description
ITT Population (all randomized participants regardless of whether or not the participant received treatment) with baseline measurements.
reporting Status
POSTED
time Frame
Week 1 through Week 24
title
Mean Hemoglobin Change Over 24 Weeks
type
SECONDARY
unit Of Measure
g/dL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice