Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP
Status:
Terminated
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to evaluate the safety of multiple doses of
Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia
Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be
studied.
Patients will be enrolled into 1 of 3 dose groups and receive 4 weekly IV doses of PRTX-100.
A Safety Monitoring Committee will review safety data through Day 28 for the first 5 patients
in a dose group before escalation to the next higher dose level. Patients will be followed
for 8 weeks after dosing for safety, PK, immunogenicity and effect on platelet
count(pharmacodynamics).