Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP

Idiopathic Thrombocytopenic Purpura (ITP) Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00571467
• Other study ID #: PRTX-100A-201
• Status: Terminated
• Phase: Phase 1
• Start date: December 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2018
• Source: Protalex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura (ITP)
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• PRTX-100 (Staphylococcal protein A)
4 weekly IV (in the vein) doses of 1 of the 3 following PRTX-100 dose levels: Cohort 1: 0.075 mcg/kg Cohort 2: 0.15 mcg/kg Cohort 3: 0.30 mcg/kg

Locations

Country	Name	City	State
Australia	Royal Brisbane	Brisbane	Queensland
Australia	Freemantle Hospital	Fremantle	Western Australia
Australia	Canberra Hospital	Garran	Australian Capital Territory
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	St. George Hospital	Sydney	New South Wales
New Zealand	Middlemore Hospital	Otahuhu	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Protalex, Inc.

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the overall safety of PRTX-100 during the 3 month study duration		3 months
Secondary	Characterize the pharmacokinetics of multiple doses of PRTX-100		over the first 35 days
Secondary	Explore immunogenicity of multiple doses of PRTX-10		3 months
Secondary	Evaluate treatment effect on platelet count		3 months