Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP
- Conditions
- Idiopathic Thrombocytopenic Purpura (ITP)
- Interventions
- Registration Number
- NCT00571467
- Lead Sponsor
- Protalex, Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PRTX-100 (Staphylococcal protein A) PRTX-100 (Staphylococcal protein A) Cohort 1: 0.075 mcg/kg Cohort 2: 0.15 mcg/kg Cohort 3: 0.30 mcg/kg
- Primary Outcome Measures
Name Time Method Evaluate the overall safety of PRTX-100 during the 3 month study duration 3 months
- Secondary Outcome Measures
Name Time Method Explore immunogenicity of multiple doses of PRTX-10 3 months Evaluate treatment effect on platelet count 3 months Characterize the pharmacokinetics of multiple doses of PRTX-100 over the first 35 days
Trial Locations
- Locations (7)
St. George Hospital
🇦🇺Sydney, New South Wales, Australia
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, 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