rhTPO Dose Escalation vs Eltrombopag Switch in ITP
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-75
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
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;
Trial design
Treatments tested in this trial
- Recombinant Human Thrombopoietin（rhTPO）
- Eltrombopag PfOS
Treatment groups
112 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov