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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   Information provided by Protalex, Inc.
First Received: December 10, 2007   Last Updated: January 8, 2009   History of Changes

December 10, 2007
January 8, 2009
December 2007
December 2009   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00571467 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
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)
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)

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).

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment
Idiopathic Thrombocytopenic Purpura (ITP)
Drug: PRTX-100 (Staphylococcal protein A)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
21
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Edward Bernton, MD ebernton@protalex.com
Australia,   New Zealand
 
NCT00571467
Edward Bernton, MD, Medical Director, Protalex, Inc.
PRTX-100A-201
Protalex, Inc.
 
Study Director: Edward Bernton, MD Protalex, Inc.
Protalex, Inc.
January 2009

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