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

This study has been terminated.
(Terminated due to recruitment not meeting expectations.)
Sponsor:
Information provided by (Responsible Party):
Protalex, Inc.
ClinicalTrials.gov Identifier:
NCT00571467
First received: December 10, 2007
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Idiopathic Thrombocytopenic Purpura (ITP)
Drug: PRTX-100 (Staphylococcal protein A)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Protalex, Inc.:

Primary Outcome Measures:
  • Evaluate the overall safety of PRTX-100 during the 3 month study duration [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetics of multiple doses of PRTX-100 [ Time Frame: over the first 35 days ] [ Designated as safety issue: No ]
  • Explore immunogenicity of multiple doses of PRTX-10 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Evaluate treatment effect on platelet count [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: December 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571467

Locations
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.
Investigators
Study Director: Edward Bernton, MD Protalex, Inc.
  More Information

No publications provided

Responsible Party: Protalex, Inc.
ClinicalTrials.gov Identifier: NCT00571467     History of Changes
Other Study ID Numbers: PRTX-100A-201
Study First Received: December 10, 2007
Last Updated: November 1, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014