A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
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ClinicalTrials.gov Identifier: NCT00194987 |
Recruitment Status
:
Recruiting
First Posted
: September 19, 2005
Last Update Posted
: February 1, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alloimmune Thrombocytopenia Fetal Alloimmune Thrombocytopenia | Drug: IVIG (Intravenous Immunoglobulin) | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia |
Study Start Date : | April 2001 |
Estimated Primary Completion Date : | June 30, 2017 |
Estimated Study Completion Date : | June 30, 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: 3 |
Drug: IVIG (Intravenous Immunoglobulin)
one to two mg per kg once-twice weekly
|
- To raise the platelet count of affected fetus. [ Time Frame: 20-30 weeks ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pregnant women are eligible for inclusion into the Very High Risk Group if they:
- are PLA-1 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
Pregnant women are eligible for inclusion into the High Risk Group if they:
- 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
Pregnant women are eligible for inclusion into the Standard Risk Group if they:
- 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
Exclusion Criteria:
Women are not eligible for inclusion into the Very High Risk Group if they:
- have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation
- are greater than 19 weeks gestation
Women are not eligible for inclusion into the High Risk Group if they:
- have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation
- are greater than 30 weeks gestation
Women are not eligible for inclusion into the Standard Risk Group if they:
- have had a previous child who suffered an antenatal hemorrhage
- are greater than 30 weeks gestation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194987
Contact: James B. Bussel, M.D. | 212-746-3474 | jbussel@med.cornell.edu | |
Contact: Arelys M Rocha, BS, BA, CCRC | 212-746-3423 | arr7008@med.cornell.edu |
United States, New York | |
New York Presbyterian Hospital-Weill Cornell Medical Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: James B. Bussel, M.D. 212-746-3474 jbussel@med.cornell.edu | |
Principal Investigator: James B Bussel, M.D. |
Principal Investigator: | James B Bussel, M.D. | Weill Medical College of Cornell University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00194987 History of Changes |
Other Study ID Numbers: |
0102004801 |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | February 1, 2017 |
Last Verified: | January 2017 |
Keywords provided by Weill Medical College of Cornell University:
Alloimmune thrombocytopenia Fetal alloimmune thrombocytopenia |
Additional relevant MeSH terms:
Thrombocytopenia Blood Platelet Disorders Hematologic Diseases Immunoglobulins Antibodies |
Immunoglobulins, Intravenous gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |