Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP

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).

Timeline

Start

2007-12

Primary completion

2009-03

Completion

2009-03

Outcome

Outcome not reported

Stopped (Enrollment): “Terminated due to recruitment not meeting expectations.”

Drugs

Indications