TriangleNCT03246529 · OUTCOME
Subjects With Graft Durability at 100 Days Post Transplant/ Early Termination
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of responders
- Interval / dispersion
- Not reported
- Time frame
- Day 100 Post-Transplantation (± 7 days)
What was measured
Subjects achieving graft durability were defined as meeting the following 2 criteria: * Platelet count ≥50 × 10\^9/L without transfusion for at least 2 weeks. * Hemoglobin level ≥10 g/dL with no erythropoietin support or transfusions for at least 1 month. This analysis was performed in part 2 of the study only.
Analysis population: Post Transplantation analysis set (all randomized subjects treated, with at least 1 apheresis session, and who underwent transplantation). Graft durability was not assessed during Part 1 of the study.
Groups in this outcome
BL-8040 + G-CSF Part 2
Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
Placebo + G-CSF Part 2
Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
| Group | Source count |
|---|---|
| BL-8040 + G-CSF Part 2 | 77 |
| Placebo + G-CSF Part 2 | 37 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BL-8040 + G-CSF Part 2 | 92.2 | Not reported | Not reported | Not reported | Not reported |
| Placebo + G-CSF Part 2 | 91.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 92.2
- group Id
- OG001
- value
- 91.9
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 37
- units
- Participants
- description
- Subjects achieving graft durability were defined as meeting the following 2 criteria: * Platelet count ≥50 × 10\^9/L without transfusion for at least 2 weeks. * Hemoglobin level ≥10 g/dL with no erythropoietin support or transfusions for at least 1 month. This analysis was performed in part 2 of the study only.
- groups
- description
- Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
- id
- OG000
- title
- BL-8040 + G-CSF Part 2
- description
- Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
- id
- OG001
- title
- Placebo + G-CSF Part 2
- param Type
- NUMBER
- population Description
- Post Transplantation analysis set (all randomized subjects treated, with at least 1 apheresis session, and who underwent transplantation). Graft durability was not assessed during Part 1 of the study.
- reporting Status
- POSTED
- time Frame
- Day 100 Post-Transplantation (± 7 days)
- title
- Subjects With Graft Durability at 100 Days Post Transplant/ Early Termination
- type
- SECONDARY
- unit Of Measure
- Percentage of responders
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice