Pharmacokinetics and Pharmacodynamics of Pegylated Human G-CSF

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002499

Enrollment

Unknown

Registered

2012-09-15

Start date

2010-10-20

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Chemotherapy-induced neutropenia

Interventions

1:PEG-GCSF 60ug/kg

2:PEG-GCSF100ug/kg

3:PEG-GCSF 120ug/kg

4:G-CSF 5ug/kg

Eligibility

Sex/Gender

All

Age

21 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients were males or females,aged 20 to 70 years to be diagnosed as NSCLC; 2. Weight 50-85kg (including 50 and 85kg); 3. Patients diagnosed with non-small cell lung cancer by histopathology, Chemotherapy na?ve or postoperative adjuvant therapy; 4. White blood cell count range >=3.5*10^9/L, neutrophils >=1.5*10^9/L, and platelets >=100*10^9/L, hemoglobin >=90.0 g/L, and no bleeding tendency; 5. liver function: bilirubin =3 months; 8. Written informed consent was obtained from all Subjects or witnesses commissioned by Subjects before any study-related procedure was performed.

Exclusion criteria

Exclusion criteria: 1. Patients had uncontrolled infection currently; 2. Patients had a diagnosis of bone marrow metastasis; 3. Patients with Whole brain radiotherapy or with long bone and pelvic metastasis needed for radiotherapy; 4. Combined with other malignancies;(excluded cured basal cell carcinoma and endometrial cancer); 5. Patients with Fertility do not take effective contraceptive measures; 6. Patients with underlying Serious disease of other organs; 7. Patients with Symptomatic brain metastases, serious brain disease or other mental or physical disabilities; 8. Patients had Suspected history of drug abuse or Alcoholism; 9. Patients had known sensitivity to Escherichia coli–derived products; 10. Patients had known human immunodeficiency virus, or HBV virus, HCV virus infection; 11. Patients had blood donors within 3 months; 12. Patients had participated in other clinical trials Within the late 3 months; 13. Patients was thought by the researchers not fit to this study.

Design outcomes

Primary

Measure	Time frame
drug Concentration of blood;	—

Countries

China

Contacts

Public ContactShucai Zhang

lixilucky@yahoo.com.cn+86 10 89509324

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026