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

NCT00571467 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-07-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Protalex, Inc.

    lead INDUSTRY

Principal Investigators

  • Edward Bernton, MD · Protalex, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00571467 on ClinicalTrials.gov