TriangleNCT01520909 · OUTCOME
PK Assessments for Eltrombopag for Apparent Central Volume (Vc/F) and Apparent Peripheral Volume (Vp/F)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Liters (L)
- Interval / dispersion
- 95% Confidence Interval
- 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. Vc/F is defined as the volume of the central (e.g. plasma) compartment and Vp/F is defined as the volume of the peripheral compartment. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.
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
Vc/F
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eltrombopag Cohort 1 (12-17 Years) | 2.46 | Not reported | 2.20 | 2.75 | Not reported |
| Eltrombopag Cohort 2 (6-11 Years) | 1.57 | Not reported | 1.35 | 1.81 | Not reported |
| Eltrombopag Cohort 3 (1-5 Years) | 0.90 | Not reported | 0.76 | 1.05 | Not reported |
Vp/F
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eltrombopag Cohort 1 (12-17 Years) | 19.2 | Not reported | 17.7 | 20.9 | Not reported |
| Eltrombopag Cohort 2 (6-11 Years) | 11.8 | Not reported | 10.9 | 12.9 | Not reported |
| Eltrombopag Cohort 3 (1-5 Years) | 7.17 | Not reported | 6.58 | 7.81 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.20
- upper Limit
- 2.75
- value
- 2.46
- group Id
- OG001
- lower Limit
- 1.35
- upper Limit
- 1.81
- value
- 1.57
- group Id
- OG002
- lower Limit
- 0.76
- upper Limit
- 1.05
- value
- 0.90
- title
- Vc/F
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.7
- upper Limit
- 20.9
- value
- 19.2
- group Id
- OG001
- lower Limit
- 10.9
- upper Limit
- 12.9
- value
- 11.8
- group Id
- OG002
- lower Limit
- 6.58
- upper Limit
- 7.81
- value
- 7.17
- title
- Vp/F
- 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. Vc/F is defined as the volume of the central (e.g. plasma) compartment and Vp/F is defined as the volume of the peripheral compartment. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.
- dispersion Type
- 95% Confidence Interval
- 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
- GEOMETRIC_MEAN
- 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
- PK Assessments for Eltrombopag for Apparent Central Volume (Vc/F) and Apparent Peripheral Volume (Vp/F)
- type
- SECONDARY
- unit Of Measure
- Liters (L)
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Preserved source evidence · Not medical advice