IVIg Plus Low Dose rhTPO for ITP in Pregnancy

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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.