TriangleNCT01520909 · OUTCOME
Population PK Model Point Estimate for Eltrombopag for Absorption Rate-constant (Ka)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- 1/h
- Interval / dispersion
- Not reported
- Time frame
- Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)
What was measured
Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Ka is defined as the absorption rate constant. This parameter is dose independent, and the population estimate Ka is reported.
Analysis population: PK Population. Only those participants who provided pharmacokinetic samples were analyzed
Groups in this outcome
Eltrombopag Cohort 1 (12-17 Years)
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
Eltrombopag Cohort 2 (6-11 Years)
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
Eltrombopag Cohort 3 (1-5 Years)
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
| Group | Source count |
|---|---|
| Eltrombopag Cohort 1 (12-17 Years) | 33 |
| Eltrombopag Cohort 2 (6-11 Years) | 38 |
| Eltrombopag Cohort 3 (1-5 Years) | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eltrombopag Cohort 1 (12-17 Years) | 0.189 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag Cohort 2 (6-11 Years) | 0.189 | Not reported | Not reported | Not reported | Not reported |
| Eltrombopag Cohort 3 (1-5 Years) | 0.189 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.189
- group Id
- OG001
- value
- 0.189
- group Id
- OG002
- value
- 0.189
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 19
- units
- Participants
- description
- Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Ka is defined as the absorption rate constant. This parameter is dose independent, and the population estimate Ka is reported.
- groups
- description
- Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
- id
- OG000
- title
- Eltrombopag Cohort 1 (12-17 Years)
- description
- Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
- id
- OG001
- title
- Eltrombopag Cohort 2 (6-11 Years)
- description
- Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
- id
- OG002
- title
- Eltrombopag Cohort 3 (1-5 Years)
- param Type
- NUMBER
- population Description
- PK Population. Only those participants who provided pharmacokinetic samples were analyzed
- reporting Status
- POSTED
- time Frame
- Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)
- title
- Population PK Model Point Estimate for Eltrombopag for Absorption Rate-constant (Ka)
- type
- SECONDARY
- unit Of Measure
- 1/h
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice