A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

NCT00194987 | Completed Phase 2 Results

• 1 other identifier: 0102004801
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alloimmune thrombocytopenia; Fetal alloimmune thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Number of Newborns With a Birth Platelet Count > 50,000/uL

  this uses the birth platelet count of the fetuses from the study when they are born

  32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40

Secondary Outcomes (2)

• Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study

  time of ICH (range 20-40 wks)

• Number of Fetal Platelet Counts > 50,000/uL

  32 +/- 2 weeks

Study Arms (2)

IVIG x 2

EXPERIMENTAL

IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT

Drug: IVIG (Intravenous Immunoglobulin)

IVIG x 1 + prednisone

EXPERIMENTAL

IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT

Drug: IVIG (Intravenous Immunoglobulin); Drug: prednisone

Interventions

IVIG (Intravenous Immunoglobulin) DRUG

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

IVIG x 1 + prednisone; IVIG x 2

prednisone DRUG

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

IVIG x 1 + prednisone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• are PLA-1 (platelet antigen A1) negative and have known platelet incompatibility with their fetus
• have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation (as best as could be estimated)
• are less than 19 weeks gestation
• are PLA-1 negative and have known platelet incompatibility with the fetus
• have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation (as best as could be estimated)
• are between 12-30 weeks gestation
• are PLA-1 negative and have known platelet incompatibility with the fetus
• have not had a previous child who suffered an antenatal hemorrhage
• are between 20-30 weeks gestation

You may not qualify if:

• have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation
• are greater than 19 weeks gestation
• have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation
• are greater than 30 weeks gestation
• have had a previous child who suffered an antenatal hemorrhage
• are greater than 30 weeks gestation

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• New York Presbyterian Hospital: collaborator
• Columbia University: collaborator

Study Sites (1)

New York Presbyterian Hospital-Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Related Publications (2)

• Lakkaraja M, Jin JC, Manotas KC, Vinograd CA, Ferd P, Gabor J, Wissert M, Berkowitz RL, McFarland JG, Bussel JB. Blood group A mothers are more likely to develop anemia during antenatal intravenous immunoglobulin treatment of fetal and neonatal alloimmune thrombocytopenia. Transfusion. 2016 Oct;56(10):2449-2454. doi: 10.1111/trf.13779. Epub 2016 Sep 9.

  PMID: 27611703 DERIVED

• Berkowitz RL, Lesser ML, McFarland JG, Wissert M, Primiani A, Hung C, Bussel JB. Antepartum treatment without early cordocentesis for standard-risk alloimmune thrombocytopenia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):249-55. doi: 10.1097/01.AOG.0000270302.80336.dd.

  PMID: 17666597 DERIVED

MeSH Terms

Interventions

Immunoglobulins, Intravenous; Prednisone

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr James Bussel
• Organization: Weill MC

jbussel@med.cornell.edu

917-291-5091

Study Officials

• James B Bussel, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: participants and their physicians will know if they are receiving IVIG x 2 or IVIG x1 plus prednisone
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomization between 2 groups

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2001
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: November 7, 2018
• Results First Posted: November 7, 2018

Record last verified: 2018-10

Locations

US (1)