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

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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)

This study is currently recruiting participants.

Study NCT00571467. Last updated on May 1, 2008. Information provided by Protalex, Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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 ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Idiopathic Thrombocytopenic Purpura (ITP)

Intervention ^†

Drug: PRTX-100 (Staphylococcal protein A)

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

December 2007

Completion Date

January 2009

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Edward Bernton, MD

ebernton@protalex.com

Location Countries ^†

Australia, New Zealand

Administrative Information Fields

NCT ID ^†

NCT00571467

Organization ID

PRTX-100A-201

Secondary IDs ^††

Study Sponsor ^†

Protalex, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Edward Bernton, MD

Protalex, Inc.

Information Provided By

Protalex, Inc.

Verification Date

May 2008

First Received Date ^†

December 10, 2007

Last Updated Date

May 1, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.