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Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.
KRN125 is administered as a single SC dose to the Day 1. The stem cell mobilization protocols will be monitored for safety and efficacy during the mobilization period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KRN125 | Experimental | Single SC administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegfilgrastim | Drug | Single dose of SC administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7 | Baseline to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| • Period from baseline to first time peripheral blood CD34 positive cells >20 cells/μL | Baseline to Day 15 or through study completion, an average of 1 year | |
| • Time from baseline to peak peripheral blood CD34 positive cells | Baseline to Day 15 or through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hokkaido University Hospital | Sapporo | Hokkaido | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38012835 | Derived | Goto H, Sugita J, Hasegawa Y, Hayasaka K, Sunagoya K, Hatase R, Nishida M, Ichihashi Y, Odera M, Senjo H, Yokoyama S, Ara T, Shiratori S, Endo T, Hino M, Maeda Y, Sawa M, Sato N, Teshima T. Efficacy and Safety of Single-dose Pegfilgrastim for CD34 + Cell Mobilization in Healthy Volunteers: A Phase 2 Study. Transplantation. 2024 Apr 1;108(4):996-1003. doi: 10.1097/TP.0000000000004880. Epub 2024 Mar 23. |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
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Phase II, single center, open label, non-control, dose setting study
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| • Achievement of >10 cells/μL positive for CD34 in peripheral blood from baseline to Day 7 | Baseline to Day 7 |
| • Peripheral blood CD34 positive cell count | Baseline to Day 15 or through study completion, an average of 1 year |
| • Peripheral blood white blood cell count | Baseline to Day 15 or through study completion, an average of 1 year |
| • Peripheral blood neutrophil count | Baseline to Day 15 or through study completion, an average of 1 year |