NCT00571467

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

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Protalex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Idiopathic Thrombocytopenic Purpura (ITP)

Interventions

Type	Name	Description
DRUG	PRTX-100 (Staphylococcal protein A)	4 weekly IV (in the vein) doses of 1 of the 3 following PRTX-100 dose levels: * Cohort 1: 0.075 mcg/kg * Cohort 2: 0.15 mcg/kg * Cohort 3: 0.30 mcg/kg

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-12-12
• Last updated: 2018-07-20

Locations

7 sites across 2 countries: Australia, New Zealand