NCT05333744

The Combination of Prednisone and Recombinant Human Thrombopoietin for Treatment of Immune Thrombocytopenia in Pregnancy

The Combination of Prednisone and Recombinant Human Thrombopoietin vs Prednisone Monotherapy for Treatment in Immune Thrombocytopenia in Pregnancy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

Randomized, open-label study to compare the efficacy and safety of prednisone plus recombinant human thrombopoietin (rhTPO) compared to prednisone monotherapy for the treatment of immune thrombocytopenia in pregnancy

Detailed description

The investigators are undertaking a parallel group, randomized controlled trial of adults with ITP in pregnancy in China. Patients were randomized to prednisone plus rhTPO and prednisone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Prednisone	Prednisone po, 20mg per day for 2 weeks, if response (Plt 30-100×100\^g/L),gradually taper to the maintenance dose（5-10mg per day）until 6 weeks after delivery; if not response, gradually taper to withdrawal.
DRUG	Recombinant Human TPO	rhTPO im, 300U/kg per day for 2 weeks, if response (Plt 30-100×100\^g/L), taper to 300U/kg for twice per week until 6 weeks after delivery; if not response, drug withdrawal.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-06-01
• Completion: 2022-09-01
• First posted: 2022-04-19
• Last updated: 2022-04-19

Locations

1 site across 1 country: China