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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Idiopathic Thrombocytopenic Purpura (ITP)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRTX-100 (Staphylococcal protein A)

Cohort 1: 0.075 mcg/kg

Cohort 2: 0.15 mcg/kg

Cohort 3: 0.30 mcg/kg

Group Type EXPERIMENTAL

PRTX-100 (Staphylococcal protein A)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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PRTX-100

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No