search
Back to results

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

Primary Purpose

Idiopathic Thrombocytopenic Purpura (ITP)

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PRTX-100 (Staphylococcal protein A)
Sponsored by
Protalex, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura (ITP) focused on measuring Autoimmune Diseases, Bleeding Disorders, Blood and Blood Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Canberra Hospital
  • St. George Hospital
  • Royal Brisbane
  • Monash Medical Centre
  • Freemantle Hospital
  • Royal Perth Hospital
  • Middlemore Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRTX-100 (Staphylococcal protein A)

Arm Description

Cohort 1: 0.075 mcg/kg Cohort 2: 0.15 mcg/kg Cohort 3: 0.30 mcg/kg

Outcomes

Primary Outcome Measures

Evaluate the overall safety of PRTX-100 during the 3 month study duration

Secondary Outcome Measures

Characterize the pharmacokinetics of multiple doses of PRTX-100
Explore immunogenicity of multiple doses of PRTX-10
Evaluate treatment effect on platelet count

Full Information

First Posted
December 10, 2007
Last Updated
July 19, 2018
Sponsor
Protalex, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00571467
Brief Title
Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to recruitment not meeting expectations.
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protalex, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Thrombocytopenic Purpura (ITP)
Keywords
Autoimmune Diseases, Bleeding Disorders, Blood and Blood Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRTX-100 (Staphylococcal protein A)
Arm Type
Experimental
Arm Description
Cohort 1: 0.075 mcg/kg Cohort 2: 0.15 mcg/kg Cohort 3: 0.30 mcg/kg
Intervention Type
Drug
Intervention Name(s)
PRTX-100 (Staphylococcal protein A)
Other Intervention Name(s)
PRTX-100
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluate the overall safety of PRTX-100 during the 3 month study duration
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Characterize the pharmacokinetics of multiple doses of PRTX-100
Time Frame
over the first 35 days
Title
Explore immunogenicity of multiple doses of PRTX-10
Time Frame
3 months
Title
Evaluate treatment effect on platelet count
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Bernton, MD
Organizational Affiliation
Protalex, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
Country
Australia
Facility Name
St. George Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Royal Brisbane
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Monash Medical Centre
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Freemantle Hospital
City
Fremantle
State/Province
Western Australia
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Middlemore Hospital
City
Otahuhu
State/Province
Auckland
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs