CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 102 enrolled
Drug / intervention
IVIG (Intravenous Immunoglobulin) +1 moredrug
Likely dose
IVIG 1 gram per kg per infusion given once or twice weekly; prednisone 0.5 mg/kg/day (in IVIG + prednisone arm)AI-extracted
Key inclusion· 7
  • ✓PLA-1 negative with known platelet incompatibility with fetus (applies to all three risk groups)
  • ✓Very High Risk: prior child with antenatal hemorrhage prior to 28 weeks gestation
  • ✓Very High Risk: less than 19 weeks gestation
  • ✓High Risk: prior child with antenatal hemorrhage after 28 weeks gestation
Key exclusion· 6
  • ✕Very High Risk: prior child with hemorrhage after 28 weeks gestation
  • ✕Very High Risk: 19 weeks gestation or greater
  • ✕High Risk: prior child with hemorrhage prior to 28 weeks gestation
  • ✕High Risk: greater than 30 weeks gestation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00194987
NCT00194987Phase 3Completed
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A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Weill Medical College of Cornell University·interventional·Posted Sep 19, 2005·Updated Nov 7, 2018

In Brief

A Phase 3 clinical trial evaluating IVIG (Intravenous Immunoglobulin) and prednisone for Alloimmune Thrombocytopenia and Fetal Alloimmune Thrombocytopenia. Completed, enrolled 102 participants across 1 site.

Detailed Summary

The purposes of this study are to provide medical management by giving treatment to the mother that will bring up the fetal platelet count and to minimize the number of invasive procedures to the fetus (which may result in serious fetal injuries).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlloimmune Thrombocytopenia, Fetal Alloimmune Thrombocytopenia
CountriesUnited States
CollaboratorsNew York Presbyterian Hospital, Columbia University

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartApr 1, 2001
Primary CompletionJun 30, 2015
TodayJul 2, 2026
Enrollment to primary: 14.2 yearsPosted 20.8 years ago

Interventions

IVIG (Intravenous Immunoglobulin)drug

one gram per kg of IVIG per infusion given either once or twice

prednisonedrug

in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day