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

July 19, 2018 updated by: Protalex, Inc.

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia
        • Canberra Hospital
    • New South Wales
      • Sydney, New South Wales, Australia
        • St. George Hospital
    • Queensland
      • Brisbane, Queensland, Australia
        • Royal Brisbane
    • Victoria
      • Melbourne, Victoria, Australia
        • Monash Medical Centre
    • Western Australia
      • Fremantle, Western Australia, Australia
        • Freemantle Hospital
      • Perth, Western Australia, Australia
        • Royal Perth Hospital
  • New Zealand
    • Auckland
      • Otahuhu, Auckland, New Zealand
        • Middlemore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of chronic ITP > 4 months
  • Mean platelet count <50 x 10^9/L for patients not receiving corticosteroids; or mean platelet count >=50 x 10^9/L for patients receiving stable dose of corticosteroids

Exclusion Criteria:

  • Splenectomy within 45 days of screening
  • Rituximab within 6 months prior to screening
  • Cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for ITP within 3 months prior to screening
  • IVIG, WinRho or other anti-RhD within 30 days prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRTX-100 (Staphylococcal protein A)

Cohort 1: 0.075 mcg/kg

Cohort 2: 0.15 mcg/kg

Cohort 3: 0.30 mcg/kg
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
Other Names:
  • PRTX-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the overall safety of PRTX-100 during the 3 month study duration
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize the pharmacokinetics of multiple doses of PRTX-100
Time Frame: over the first 35 days
over the first 35 days
Explore immunogenicity of multiple doses of PRTX-10
Time Frame: 3 months
3 months
Evaluate treatment effect on platelet count
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protalex, Inc.

Investigators

  • Study Director: Edward Bernton, MD, Protalex, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 12, 2007

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRTX-100A-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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