Immune thrombocytopenia
Conditions
Interventions
treatment group:Romiplostim (N01) Combined with Short-Course Prednisone Therapy
Sponsors
Shanxi Province People‘s Hospitall
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Clinically confirmed immune thrombocytopenia (ITP) with either: Two consecutive platelet counts 30×10^9/L accompanied by bleeding manifestations. 2.ECOG Performance Status (PS) score: 0 to 2. 3.No prior systemic therapy for ITP (e.g., corticosteroids, immunosuppressants). 4.Age >= 60 years. 5.Adequately controlled hypertension or diabetes (e.g., blood pressure <=140/90 mmHg; HbA1c <= 7.0%). 6.Bone marrow examination showing normal or increased megakaryocyte count (consistent with ITP diagnosis). 7.No active infections (e.g., absence of fever or elevated CRP). 8.Male patients of reproductive potential must use effective contraceptive measures during and for =3 months after the study. 9.Signed and dated written informed consent.
Exclusion criteria
Exclusion criteria: 1.Hematological disorders (benign or malignant) affecting platelet count, including leukemia, myeloproliferative neoplasms, multiple myeloma, aplastic anemia, or myelodysplastic syndromes. 2.Secondary thrombocytopenia caused by solid tumors. 3.Secondary thrombocytopenia due to active infections. 4.Drug-induced secondary thrombocytopenia (e.g., receipt of immunosuppressive therapy within 1 month prior to enrollment). 5.Secondary thrombocytopenia associated with connective tissue diseases (e.g., systemic lupus erythematosus). 6.Autoimmune hemolytic anemia (AIHA). 7.Positive screening results for any of the following: Human immunodeficiency virus (HIV) antibodies or syphilis antibodies; Hepatitis C virus (HCV) antibodies with detectable HCV-RNA above the upper limit of normal (ULN) at the study site's laboratory; Hepatitis B surface antigen (HBsAg) with detectable HBV-DNA above the ULN at the study site's laboratory. 8.Fractures, active gastrointestinal ulcers, or hemorrhage. 9.Failure to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients meeting the efficacy criteria;Proportion of patients with adverse events (AEs);Incidence of bleeding symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with sustained remission;Median time to platelet count >=50×10^9/L;Changes in immune cell levels; | — |
Countries
China
Contacts
Public ContactHe Jianxia
Shanxi Provincial People‘s Hospital
Outcome results
None listed