Thrombocytopenia
Conditions
Interventions
Experimental Group:Romiplostim for Injection N01
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: >= 18 years and = 3 months; 6. Female subjects of childbearing potential must have a serum pregnancy test conducted within 3 days prior to randomization, with a negative result; and must not be lactating. Female subjects of childbearing age or male subjects with partners of childbearing age must agree to use contraceptive measures during the administration of the investigational drug and for 6 months after the last dose of the investigational drug; 7. Voluntary and signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Allergy or contraindications to the investigational drug; 2.Platelet count 3×ULN (upper limit of normal) Total bilirubin (TBIL) > 1.5×ULN *(Exception: Patients with liver metastases may enroll if ALT/AST = 1.5×ULN OR creatinine clearance (CrCL) <= 50 mL/min (calculated by Cockcroft-Gault formula); 11.History of major bleeding events within 2 weeks prior to screening, including but not limited to: Gastrointestinal bleeding (e.g., hematemesis, melena) Genitourinary bleeding (e.g., gross hematuria) Central nervous system hemorrhage (e.g., intracranial bleeding); 12.Participation in any other investigational drug or device clinical trial within 3 months prior to screening; 13.Patients with any of the following infectious or chronic liver conditions: Hepatitis C virus (HCV): Anti-HCV antibody-positive and HCV-RNA above the upper limit of detection at the study site laboratory. Hepatitis B virus (HBV): HBsAg-positive and HBV-DNA above the upper limit of detection at the study site laboratory. Severe cirrhosis (e.g., Child-Pugh class B/C). HIV antibody-positive. Active syphilis (confirmed by treponemal/non-treponemal testing). 14.HIV Infection; 15.Other exclusion criteria per investigator judgment: Conditions that may compromise study integrity or require premature discontinuation, including: Substance abuse (e.g., alcoholism, illicit drug use). Concurrent severe comorbidities (e.g., uncontrolled psychiatric disorders, other life-threatening illnesses). Clinically significant lab abnormalities not otherwise specified. Psychosocial factors (e.g., non-adherence risk, lack of support).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate of Romiplostim for Injection N01; | — |
Countries
China
Contacts
Public ContactChengping Li
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed