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)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000431426

Enrollment

Registered

2007-08-24

Start date

2007-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to -2147483648 No limit

Healthy volunteers

Inclusion criteria

• 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 criteria

• 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

Outcome results