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RECRUITING
NCT06577909
PHASE2

Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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.

Official title: Prednisone Plus IVIg Compared With Prednisone for Immune Thrombocytopenia During Pregnancy

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-10-19

Completion Date

2025-12-31

Last Updated

2024-08-29

Healthy Volunteers

No

Interventions

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

Locations (1)

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China