NCT00571467

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).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2007

Geographic Reach
2 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

December 10, 2007

Last Update Submit

July 19, 2018

Conditions

Idiopathic Thrombocytopenic Purpura (ITP)

Keywords

Autoimmune DiseasesBleeding DisordersBlood and Blood Disorders

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (3)

  • Characterize the pharmacokinetics of multiple doses of PRTX-100

    over the first 35 days

  • Explore immunogenicity of multiple doses of PRTX-10

    3 months

  • Evaluate treatment effect on platelet count

    3 months

Study Arms (1)

PRTX-100 (Staphylococcal protein A)

EXPERIMENTAL

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

Drug: PRTX-100 (Staphylococcal protein A)

Interventions

PRTX-100 (Staphylococcal protein A)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

Also known as: PRTX-100
PRTX-100 (Staphylococcal protein A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Canberra Hospital

Garran, Australian Capital Territory, Australia

Location

St. George Hospital

Sydney, New South Wales, Australia

Location

Royal Brisbane

Brisbane, Queensland, Australia

Location

Monash Medical Centre

Melbourne, Victoria, Australia

Location

Freemantle Hospital

Fremantle, Western Australia, Australia

Location

Royal Perth Hospital

Perth, Western Australia, Australia

Location

Middlemore Hospital

Otahuhu, Auckland, New Zealand

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, IdiopathicAutoimmune DiseasesHemostatic DisordersHematologic Diseases

Interventions

Staphylococcal Protein A

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Edward Bernton, MD

    Protalex, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 12, 2007

Study Start

December 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations

NZ(1)AU(6)