Clinical trial · Interventional
The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents
The Study on the Pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
NCT02953730CI-TRIAL-00024704completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoid Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-rhG-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-rhG-CSF
- interventionNames
- Drug: PEG-rhG-CSF
Primary outcomes (3)
- measure
- peak concentration(Cmax)
- timeFrame
- 1 year
- measure
- elimination half life(t 1/2kel)
- timeFrame
- 1 year
- measure
- area under the curve(AUC)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age≤18 years old, gender no limited. 2. Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology. 3. Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen. 4. Previously not received radiotherapy. 5. Karnofsky Performance Scores ( KPS)≥60. 6. The expected survival time was \>3 months. 7. Neutropenia or agranulocytosis, no bleeding tendency. 8. No significant cardiac dysfunction or metabolic disease. 9. TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） \< 2.5×ULN（upper limit of normal）. 10. BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）\<1.5×ULN. 11. Written informed consent are acquired. Exclusion Criteria: 1. With a history of systemic radiotherapy. 2. Infection difficult to control, the body temperature ≥ 38℃. 3. Other situation that investigators consider as contra-indication for this study.
References
Publications (0)
Data not yet available
No reference posted for this study.