NCT06577909

Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy

Prednisone Plus IVIg Compared With Prednisone for Immune Thrombocytopenia During Pregnancy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy.

Detailed description

The investigators are undertaking a prospective, parallel group, multicenter, randomized controlled trial in pregnant patients with treat-naive ITP. A total of 100 participants are randomized to two groups with the 1:1 ratio: prednisone plus IVIg group versus prednisone monotherapy group. Participants will receive prednisone 20mg per day for 4 weeks plus IVIg 400mg/Kg (total dose ≤20g per day) for 5 days or prednisone 20mg monotherapy per day for 4 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Time to response and platelet counts of newborns are investigated. Adverse events including participants and their newborns are also recorded throughout and after the study.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Prednisone	Prednisone po, 20mg per day for 4 weeks, if response (Plt 30-100×100\^g/L), gradually taper to the maintenance dose of 5-10mg per day until 6 weeks after delivery; if not response, gradually taper to withdrawal.
DRUG	IVIg	IVIg 400mg/kg (≤20g for the total dose) per day for 5 days, and repeated in the case of lack of response by day 14

Timeline

• Start date: 2023-10-19
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-08-29
• Last updated: 2024-08-29

Locations

1 site across 1 country: China