A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

NCT00194987 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2018-11-07

Study results available
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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).

Conditions

  • Alloimmune Thrombocytopenia
  • Fetal Alloimmune Thrombocytopenia

Interventions

DRUG

IVIG (Intravenous Immunoglobulin)

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

DRUG

prednisone

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

Sponsors & Collaborators

  • New York Presbyterian Hospital

    collaborator OTHER
  • Columbia University

    collaborator OTHER
  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • James B Bussel, M.D. · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00194987 on ClinicalTrials.gov