Idiopathic Thrombocytopenic Purpura (ITP) Clinical Trial
Official title:
An Open Label, Sequential, Dose Escalation, Repeat-dose Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRTX-100 in Adult Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
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).
n/a
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