Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577909
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Prednisone Plus IVIg vs Prednisone for ITP During Pregnancy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prednisone Plus IVIg Compared With Prednisone for Immune Thrombocytopenia During Pregnancy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVIg
Brief 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 11 ratio prednisone plus IVIg group versus prednisone monotherapy group Participants will receive prednisone 20mg per day for 4 weeks plus IVIg 400mgKg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None