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This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients | Experimental | A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy |
|
| Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients | Experimental | A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy |
|
| Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients | Experimental | A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy |
|
| Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients | Experimental | A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tripegfilgrastim | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter | Time to reach Cmax of Tripegfilgrastim [Tmax] | Day 1(Hour 0) ~ Day 21 |
| PK parameter | Peak plasma concentration of Tripegfilgrastim [Cmax] | Day 1(Hour 0) ~ Day 21 |
| PK parameter | Area under the plasma concentration of Tripegfilgrastim versus time curve [AUC] | Day 1(Hour 0) ~ Day 21 |
| PK parameter | Half-life of Tripegfilgrastim [T1/2] | Day 1(Hour 0) ~ Day 21 |
| PK parameter | The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered [Ctrough] | Day 1(Hour 0) ~ Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| PD parameter | Peak plasma concentration of Absolute Neutrophil Count [ANCmax] | Day 1(Hour 0) ~ Day 14 |
| PD parameter | Area under the plasma concentration of Absolute Neutrophil Count versus time curve [AUC(ANC)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 82 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37559343 | Derived | Lee S, Hong KT, Jang IJ, Yu KS, Kang HJ, Oh J. Semimechanistic pharmacokinetic-pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1319-1334. doi: 10.1002/psp4.13012. Epub 2023 Aug 9. | |
| 34605552 | Derived | Lee S, Hong KT, Moon SJ, Choi JY, Hong CR, Shin HY, Cho JY, Jang IJ, Yu KS, Oh J, Kang HJ. Pharmacokinetic and Pharmacodynamic Characteristics of Tripegfilgrastim, a Pegylated G-CSF, in Pediatric Patients with Solid Tumors. Clin Pharmacol Ther. 2022 Jan;111(1):293-301. doi: 10.1002/cpt.2433. Epub 2021 Oct 27. |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C486981 | pegylated granulocyte colony-stimulating factor, human |
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|
| Day 1(Hour 0) ~ Day 14 |
| PD parameter | Time to reach Cmax of Absolute Neutrophil Count [Tmax(ANC)] | Day 1(Hour 0) ~ Day 14 |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |