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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00571467




Registration number
NCT00571467
Ethics application status
Date submitted
10/12/2007
Date registered
12/12/2007
Date last updated
20/07/2018

Titles & IDs
Public title
Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP
Scientific 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)
Secondary ID [1] 0 0
PRTX-100A-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Thrombocytopenic Purpura (ITP) 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PRTX-100 (Staphylococcal protein A)

Experimental: PRTX-100 (Staphylococcal protein A) - Cohort 1: 0.075 mcg/kg
Cohort 2: 0.15 mcg/kg
Cohort 3: 0.30 mcg/kg


Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the overall safety of PRTX-100 during the 3 month study duration
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Characterize the pharmacokinetics of multiple doses of PRTX-100
Timepoint [1] 0 0
over the first 35 days
Secondary outcome [2] 0 0
Explore immunogenicity of multiple doses of PRTX-10
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Evaluate treatment effect on platelet count
Timepoint [3] 0 0
3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
St. George Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Brisbane - Brisbane
Recruitment hospital [4] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [5] 0 0
Freemantle Hospital - Fremantle
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Fremantle
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Protalex, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00571467
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edward Bernton, MD
Address 0 0
Protalex, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00571467