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

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

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

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)

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

U.S. FDA Resources

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:	December 2009
Estimated Primary Completion Date:	December 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

No publications provided

Responsible Party:	Protalex, Inc. ( Edward Bernton, MD, Medical Director )
Study ID Numbers:	PRTX-100A-201
Study First Received:	December 10, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00571467 History of Changes
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
Signs and Symptoms
Skin Manifestations
Autoimmune Diseases
Hemorrhagic Disorders
Thrombocytopenia

Immune System Diseases
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic

ClinicalTrials.gov processed this record on November 27, 2009