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Study on the Safety and Efficacy of Tripegfilgrastim Injection in Pediatric Patients with Non-Myeloid Malignancies Undergoing Chemotherapy

Study on the Safety and Efficacy of Tripegfilgrastim Injection in Pediatric Patients with Non-Myeloid Malignancies Undergoing Chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124922
Enrollment
Unknown
Registered
2026-05-19
Start date
2026-05-21
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-myeloid childhood tumors

Interventions

Experimental group:Telpegfilgrastim Injection

Sponsors

Bejing Tongren Hospital, Capital Medical Uniersity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 3 to 38.3°C (axillary temperature >38.1°C), or oral temperature >38.0°C (axillary temperature >37.8°C) measured twice consecutively within 2 hours, accompanied by absolute neutrophil count (ANC) =50 or Lansky Performance Score (LPS) >=50; 5.Normal bone marrow hematopoietic function (ANC >=1.5×10^9/L, platelet count (PLT) >=80×10^9/L, hemoglobin (Hb) >=75g/L, white blood cell count (WBC) >=3.0×10^9/L, and all indices do not exceed the upper limit of normal range); 6.Expected survival of at least 6 months; 7.Written informed consent obtained.

Exclusion criteria

Exclusion criteria: 1.Received any recombinant human granulocyte colony-stimulating factor (rhG-CSF) within 3 weeks prior to study enrollment; 2.Received any antibody-drug conjugate (ADC) or other drugs with potential hematological toxicity within 3 weeks prior to study enrollment; 3.Patients who have undergone hematopoietic stem cell transplantation or organ transplantation; 4.Participated in other clinical trials of investigational drugs within 2 months before enrollment; 5.Patients with uncontrolled infection and body temperature >=38°C; 6.Liver function test results: total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) all >2.5 times the upper limit of normal (ULN); 7.Renal function test result: serum creatinine (Cr) >2 times the upper limit of normal (ULN); 8.Any other condition considered by the investigator to be a contraindication to this study.

Design outcomes

Primary

MeasureTime frame
Neutrophil count;

Countries

China

Contacts

Public ContactZhang Yi

Bejing Tongren Hospital, Capital Medical Uniersity

yichang-1@163.com+86 10 58266622

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026