Not provided
Not provided
Not provided
Not provided
Not provided
Terminated due to recruitment not meeting expectations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRTX-100 (Staphylococcal protein A) | Experimental | Cohort 1: 0.075 mcg/kg Cohort 2: 0.15 mcg/kg Cohort 3: 0.30 mcg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRTX-100 (Staphylococcal protein A) | Drug | 4 weekly IV (in the vein) doses of 1 of the 3 following PRTX-100 dose levels:
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the overall safety of PRTX-100 during the 3 month study duration | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the pharmacokinetics of multiple doses of PRTX-100 | over the first 35 days | |
| Explore immunogenicity of multiple doses of PRTX-10 | 3 months | |
| Evaluate treatment effect on platelet count |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edward Bernton, MD | Protalex, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canberra Hospital | Garran | Australian Capital Territory | Australia | |||
| St. George Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3 months |
| Sydney |
| New South Wales |
| Australia |
| Royal Brisbane | Brisbane | Queensland | Australia |
| Monash Medical Centre | Melbourne | Victoria | Australia |
| Freemantle Hospital | Fremantle | Western Australia | Australia |
| Royal Perth Hospital | Perth | Western Australia | Australia |
| Middlemore Hospital | Otahuhu | Auckland | New Zealand |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D001327 | Autoimmune Diseases |
| D020141 | Hemostatic Disorders |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013205 | Staphylococcal Protein A |
| ID | Term |
|---|---|
| D000942 | Antigens, Bacterial |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided