A Phase 1, open label, repeat-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)
Protalex, Inc.
21 participants
Oct 1, 2007
Interventional
Conditions
Summary
The primary objective of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100). Patients may be enrolled into 1 of 3 dose groups. A Safety Committee will review safety data through Day 28 for the first 5 patients in a dose group. Only upon the Safety Committee's approval will the next higher dose group be enrolled and dosed.
Eligibility
Inclusion Criteria2
- Diagnosis of chronic ITP >4 months
- Mean platelet count <50x109/L within 30 days prior to study start for patients not receiving corticosteroids; <90x109/L within 30 days prior to study start for patients receiving stable dose of corticosteroids
Exclusion Criteria5
- Splenectomy within 45 days of screening
- Clinically significant history or evidence (as determined by the Investigator) of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorders which would increase risk to the patient in this study
- Treatment with rituximab within 6 months prior to screening
- Treatment with cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for ITP within 3 months prior to screening, with the exception of steroid sparing adjunctive treatment with cyclosporine or azathioprine
- Treatment with intravenous immunoglobulin (IVIG), WinRho® or other anti-RhD within 30 days prior to screening
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Sequential cohorts of patients will receive 4 weekly intravenous doses of PRTX-100: Cohort 1 (0.075 mcg/kg), Cohort 2 (0.15 mcg/kg), Cohort 3 (0.30 mcg/kg). After a Safety Monitoring Committee reviews safety data through Day 28 for the first 5 patients in a dose group and approves dose escalation, the next dose group will be enrolled and dosed at the next higher dose level.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12607000431426