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) - Tabular View

Tracking Information

First Received Date ^ICMJE

December 10, 2007

Last Updated Date

January 8, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00571467 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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)

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).

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment

Condition ^ICMJE

Idiopathic Thrombocytopenic Purpura (ITP)

Intervention ^ICMJE

Drug: PRTX-100 (Staphylococcal protein A)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Edward Bernton, MD

ebernton@protalex.com

Location Countries ^ICMJE

Australia, New Zealand

Administrative Information

NCT ID ^ICMJE

NCT00571467

Responsible Party

Edward Bernton, MD, Medical Director, Protalex, Inc.

Study ID Numbers ^ICMJE

PRTX-100A-201

Study Sponsor ^ICMJE

Protalex, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Edward Bernton, MD

Protalex, Inc.

Information Provided By

Protalex, Inc.

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP