rhTPO Dose Escalation vs Eltrombopag Switch in ITP (NCT07476846) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
rhTPO Dose Escalation vs Eltrombopag Switch in ITP
112 participantsStarted 2026-04
Plain-language summary
This study is a prospective, multicenter, randomized controlled study, planning to enroll 110 ITP patients who failed to respond to conventional-dose rhTPO (300 IU/kg/d) after 14 days of treatment (PLT \< 30×10⁹/L). After a 2-week washout period, they will be randomized to the rhTPO double-dose group (Group A) and EPAG-pfos group (Group B), with blood routine monitored weekly and doses adjusted according to platelet levels, comparing the response rates of the two groups at 6 weeks after switching treatment.
Who can participate
Age range12 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 12-75 years, either sex;
✓. ECOG performance status 0-1;
✓. Diagnosis of ITP confirmed by bone marrow biopsy (valid within 3 months) or other relevant examinations;
✓. Patients who failed short-term rhTPO second-line treatment (≤14 days of medication) (PLT \< 30×10⁹/L);
✓. Major organ function must meet the following requirements (based on normal values at the clinical trial center):
✓. Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; no abnormalities other than ITP, except: a) PLT \< 30×10⁹/L at Day 1 visit or within 48 hours of Day 1 is acceptable for enrollment; b) Hemoglobin: if anemia is clearly due to ITP (excessive bleeding related to thrombocytopenia), subjects with hemoglobin below the lower limit of normal may be enrolled based on investigator judgment;
✓. Blood biochemistry: total bilirubin (TBIL) ≤ 1.5×ULN; ALT, AST, or ALP ≤ 3×ULN; serum creatinine (Cr) ≤ 1.5×ULN with creatinine clearance ≥ 50 mL/min;
✓. Coagulation function: prothrombin time (PT) within ±3s of normal range; activated partial thromboplastin time (APTT) ≤ 1.5×ULN unless on medications known to alter INR and APTT; no history of coagulation abnormalities other than ITP;
Exclusion criteria
✕. Refractory ITP patients (failure of first-line and second-line thrombopoietic drugs and CD20 monoclonal antibody treatment, or splenectomy failure/postoperative relapse);
✕. Pregnant or lactating patients;
What they're measuring
1
Platelet Response Rate (RR) at 6 weeks after switching treatment: proportion of patients with PLT ≥ 30×10⁹/L, at least 2-fold increase from baseline platelet count, and no bleeding manifestations
Timeframe: 6th week after treatment conversion (day 42, visitation window allowed: Day 41 to day 43)
Trial details
NCT IDNCT07476846
SponsorInstitute of Hematology & Blood Diseases Hospital, China
✕. Evidence of secondary causes of ITP (e.g., untreated Helicobacter pylori infection, leukemia, lymphoma, autoimmune diseases such as SLE, Hashimoto's thyroiditis) or drug-induced (e.g., anticonvulsants, antibiotics, heparin), or bicytopenia/pancytopenia such as Evans syndrome, immune-related cytopenias, etc.;
✕. History or current presence of primary diseases other than ITP causing thrombocytopenia (e.g., primary myelodysplastic syndrome \[MDS\], congenital bone marrow failure diseases \[e.g., Fanconi anemia, dyskeratosis congenita\], aplastic anemia \[AA\]), and judged by investigator as unsuitable for this study;
✕. History of intracranial hemorrhage or other important organ severe bleeding (\>CTC AE Grade 3), or history of symptomatic gastrointestinal bleeding (e.g., hematemesis, melena) within 6 months before screening (occult blood test positivity without symptoms/signs and hemorrhoids excluded);
✕. History of any arterial or venous thrombosis within 6 months before enrollment (including stroke, TIA, MI, DVT, or PE) AND presence of at least 2 of the following risk factors: hormone replacement therapy, oral contraceptives (including estrogen), smoking, diabetes, hypercholesterolemia, drug-controlled hypertension, hereditary coagulation disorders;
✕. Severe cardiovascular disease within 6 months before enrollment (NYHA Class III-IV), known arrhythmia increasing thromboembolic risk such as atrial fibrillation, coronary stent implantation, angioplasty, or post-CABG patients;