RecruitingPhase 1ACTRN12607000431426

A Phase 1, open label, repeat-dose, dose escalation study of the safety and tolerability of Staphylococcal protein A in adult patients with chronic Idiopathic Thrombocytopenic Purpura (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)


Sponsor

Protalex, Inc.

Enrollment

21 participants

Start Date

Oct 1, 2007

Study Type

Interventional

Conditions

Summary

The primary objective of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100). Patients may be enrolled into 1 of 3 dose groups. A Safety Committee will review safety data through Day 28 for the first 5 patients in a dose group. Only upon the Safety Committee's approval will the next higher dose group be enrolled and dosed.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing the safety of a protein called PRTX-100 (derived from Staphylococcal bacteria) in adults with chronic immune thrombocytopenic purpura (ITP). ITP is a condition where the immune system destroys platelets — cells needed for blood to clot — leading to a high risk of bleeding. Multiple doses of PRTX-100 will be given at gradually increasing levels to three groups, with safety closely monitored throughout. The study is a carefully staged safety trial. You may be eligible if: - You are 18 years of age or older - You have had ITP for more than 4 months - Your platelet count is below 50 x 10^9/L (if not on steroids) or below 90 x 10^9/L (if on steroids) in the 30 days before the study You may NOT be eligible if: - You had a splenectomy (spleen removal) in the last 45 days - You have a significant heart, lung, liver, kidney, nerve, or mental health condition - You received rituximab in the last 6 months - You received other ITP treatments (cyclophosphamide, vincristine, IVIG, or anti-RhD) within 3 months (or 30 days for IVIG/anti-RhD) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Sequential cohorts of patients will receive 4 weekly intravenous doses of PRTX-100: Cohort 1 (0.075 mcg/kg), Cohort 2 (0.15 mcg/kg), Cohort 3 (0.30 mcg/kg). After a Safety Monitoring Committee review

Sequential cohorts of patients will receive 4 weekly intravenous doses of PRTX-100: Cohort 1 (0.075 mcg/kg), Cohort 2 (0.15 mcg/kg), Cohort 3 (0.30 mcg/kg). After a Safety Monitoring Committee reviews safety data through Day 28 for the first 5 patients in a dose group and approves dose escalation, the next dose group will be enrolled and dosed at the next higher dose level.


Locations(1)

New Zealand

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