This is an open-label, multiple-dose study to evaluate the safety and efficacy of BG9588 in up to 23 subjects with chronic refractory immune thrombocytopenia (ITP) who previously participated in Biogen study C96-1000. Subjects will receive BG9588 via a 15 min IV infusion every 4 weeks for a total of up to 13 doses. The initial dose will be 3mg/kg continued for three consecutive treatment cycles. Subsequent dosing will be based on the platelet response during the third of three consecutive treatment cycles as follows: 1) those whose counts were greater than 50K on both the Day 1 and Day 15 determinations of the third treatment cycle will have their dose reduced; 2) those with both the Day 1 and Day 15 platelet count less than 30K will have their dose increased; 3) all others will maintain their dose. The maximum dose will not exceed 10 mg/kg. The BG9588 dosing may be delayed for subjects with major bleeding events or other medical events such as infection.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000048-40
Application #
6441694
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Northwestern University at Chicago
Department
Type
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611
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