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NCT05634824
IVIg Plus Low Dose rhTPO for ITP in Pregnancy
Conditions: Immune Thrombocytopenia, Pregnancy Related
Sex: Female
Ages: 18 Years – 50 Years
Phase: PHASE2
Enrollment: 50
Sponsor: Peking University People's Hospital
Summary
Randomized, open-label, multicenter study to investigate the efficacy and safety of IVIg plus low-dose recombinant thrombopoietin in pregnant patients with corticosteroid or IVIg monotherapy-resistant ITP.
Eligibility Criteria
Inclusion Criteria:Patients have a diagnosis of primary ITP before or first onset during pregnancy; Patients ≥ 18 years; patients complicate with bleeding manifestations and/or have a platelet count < 30 × 10^9/L and failed to respond to initial treatment of corticosteroids or intravenous immunoglobulin (IVIg) monotherapy or relapsed during the tapering or discontinuation of corticosteroids.Exclusion Criteria:Patients whose thrombocytopenia was secondary to cancer (solid tumor or leukemia), infections, preeclampsia, and HELLP syndrome (hemolysis, elevated liver enzymes, low platelets), and those who had primary immune deficiency, and other hematology or connective tissue diseases during follow-up; patients have heart, kidney, liver, or lung dysfunction; patients received chemotherapy or anticoagulants within 3 months before screening or other second-line ITP-specific treatments within 3 months before screening.
Source: ClinicalTrials.gov (NCT05634824). StuddyBuddy aggregates publicly available trial information.