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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00571467
Recruitment Status : Terminated (Terminated due to recruitment not meeting expectations.)
First Posted : December 12, 2007
Last Update Posted : November 2, 2012
Information provided by (Responsible Party):
Protalex, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Idiopathic Thrombocytopenic Purpura (ITP) Drug: PRTX-100 (Staphylococcal protein A) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : December 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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 Name: PRTX-100

Primary Outcome Measures :
  1. Evaluate the overall safety of PRTX-100 during the 3 month study duration [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Characterize the pharmacokinetics of multiple doses of PRTX-100 [ Time Frame: over the first 35 days ]
  2. Explore immunogenicity of multiple doses of PRTX-10 [ Time Frame: 3 months ]
  3. Evaluate treatment effect on platelet count [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00571467

Australia, Australian Capital Territory
Canberra Hospital
Garran, Australian Capital Territory, Australia
Australia, New South Wales
St. George Hospital
Sydney, New South Wales, Australia
Australia, Queensland
Royal Brisbane
Brisbane, Queensland, Australia
Australia, Victoria
Monash Medical Centre
Melbourne, Victoria, Australia
Australia, Western Australia
Freemantle Hospital
Freemantle, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
New Zealand
Middlemore Hospital
Otahuhu, Auckland, New Zealand
Sponsors and Collaborators
Protalex, Inc.
Study Director: Edward Bernton, MD Protalex, Inc.

Responsible Party: Protalex, Inc. Identifier: NCT00571467     History of Changes
Other Study ID Numbers: PRTX-100A-201
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: November 2012

Keywords provided by Protalex, Inc.:
Autoimmune Diseases
Bleeding Disorders
Blood and Blood Disorders

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases