Trial Information

Summary: A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy [AMG 531 20030105]

It has been shown that the study drug, AMG 531, may be able to increase platelet counts in patients with Immune Thrombocytopenic Purpura (ITP). The purpose of this research study is to determine whether AMG 531 is safe and effective as a treatment of thrombocytopenia in patients with ITP who have had a splenectomy. The study is considered research because AMG 531 has not been approved by the FDA. In this research study all patients will be randomly assigned to receive either AMG 531 or a placebo (a medicine that looks like AMG 531 but contains no medication).
The study medication and procedures will be provided for free. Patients will be reimbursed for time and travel expenses. There will be weekly clinic visits for up to 9 months.
Compensation Provided

Patient Inclusion/Exclusion Criteria:

You may be able to participate if you
-are male or female at least 18 years old
-have been diagnosed with ITP (Immune Thrombocytopenic Purpura)
-have had a splenectomy for the treatment of ITP
-meet additional criteria

You will not be able to participate if you
-have any known history of bone marrow stem cell disorder
-have any active malignancy
-are pregnant or breastfeeding

Contact:

Louis Aledort, MD, Prinicpal Investigator
Mount Sinai Medical Center
One Gustave L. Levy Place

New York, NY 10029
Telephone: 212-241-7971
Fax: 212-987-3326
Email:

 

If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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Trial listings updated: June 1, 2008 at 5:44:46 AM


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