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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
Stopped early
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00571467