A Phase 1, Open-Label, Multiple-Dose, Dose Escalation Study of the Safety and Tolerability of Staphylococcal Protein A in Adult Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP) - Full Text View

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 I

Genetics Home Reference related topics:

hemophilia thrombotic thrombocytopenic purpura

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment

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)

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 ]

Estimated Enrollment:	21
Study Start Date:	December 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

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

Contacts


Contact: Edward Bernton, MD		ebernton@protalex.com

Locations


Australia, Australian Capital Territory
	Canberra Hospital	Recruiting
	Garran, Australian Capital Territory, Australia

Australia, New South Wales
	St. George Hospital	Recruiting
	Sydney, New South Wales, Australia

Australia, Queensland
	Royal Brisbane	Recruiting
	Brisbane, Queensland, Australia

Australia, Victoria
	Monash Medical Centre	Recruiting
	Melbourne, Victoria, Australia

Australia, Western Australia
	Freemantle Hospital	Recruiting
	Freemantle, Western Australia, Australia
	Royal Perth Hospital	Recruiting
	Perth, Western Australia, Australia

New Zealand, Auckland
	Middlemore Hospital	Recruiting
	Otahuhu, Auckland, New Zealand

Sponsors and Collaborators

Protalex, Inc.

Investigators


Study Director:	Edward Bernton, MD	Protalex, Inc.

More Information

Responsible Party:	Protalex, Inc. ( Edward Bernton, MD, Medical Director )
Study ID Numbers:	PRTX-100A-201
First Received:	December 10, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00571467
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Protalex, Inc.:

Autoimmune Diseases

Bleeding Disorders

Blood and Blood Disorders

Study placed in the following topic categories:

Purpura

Autoimmune Diseases

Hematologic Diseases

Blood Coagulation Disorders

Blood Platelet Disorders

Hemorrhage

Hemostatic Disorders

Purpura, Thrombocytopenic

Thrombocytopathy

Signs and Symptoms

Thrombocytopenia

Hemorrhagic Disorders

Thrombocytopenic purpura, autoimmune

Purpura, Thrombocytopenic, Idiopathic

Additional relevant MeSH terms:

Skin Manifestations

Immune System Diseases

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Protalex, Inc.
Information provided by:	Protalex, Inc.
ClinicalTrials.gov Identifier:	NCT00571467