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| Sponsored by: |
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 |
| Genetics Home Reference related topics: | hemophilia thrombotic thrombocytopenic purpura |
| 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) |
| 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) |
4 weekly IV (in the vein) doses of 1 of the 3 following PRTX-100 dose levels:
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Edward Bernton, MD | ebernton@protalex.com |
| 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 | |||||
| Protalex, Inc. |
| 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 |
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