Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000431426
Ethics application status
Approved
Date submitted
18/08/2007
Date registered
24/08/2007
Date last updated
7/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, open label, repeat-dose, dose escalation study of the safety and tolerability of Staphylococcal protein A in adult patients with chronic Idiopathic Thrombocytopenic Purpura (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)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Thrombocytopenic Purpura 2273 0
Condition category
Condition code
Blood 2363 2363 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sequential cohorts of patients will receive 4 weekly intravenous doses of PRTX-100: Cohort 1 (0.075 mcg/kg), Cohort 2 (0.15 mcg/kg), Cohort 3 (0.30 mcg/kg). After a Safety Monitoring Committee reviews safety data through Day 28 for the first 5 patients in a dose group and approves dose escalation, the next dose group will be enrolled and dosed at the next higher dose level.
Intervention code [1] 1983 0
Treatment: Drugs
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3262 0
Safety
Timepoint [1] 3262 0
Days 0, 1,2, 7, 14, 21, 22,23,28,35,49,63,84.
Secondary outcome [1] 5442 0
Characterize the pharamcokinetics of PRTX-100
Timepoint [1] 5442 0
During the 1st and 4th dosing of PRTX-100 at the following times: pre-dose, within 5 min post-dose, and at 30, 60 and 180 min post-dose. Samples also obtained on Days 1, 2, 7, 14, 22, 23, 28 and 35.
Secondary outcome [2] 5443 0
Explore immunogenicity of multiple doses of PRTX-100
Timepoint [2] 5443 0
Days 0 pre-dose, 14, 28, 35, 63 and 84
Secondary outcome [3] 5444 0
Evaluate treatment effect on platelet count
Timepoint [3] 5444 0
Days 28 and 35 after 1st treatment

Eligibility
Key inclusion criteria
• Diagnosis of chronic ITP >4 months
• Mean platelet count <50x109/L within 30 days prior to study start for patients not receiving corticosteroids; <90x109/L within 30 days prior to study start 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
• Clinically significant history or evidence (as determined by the Investigator) of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorders which would increase risk to the patient in this study
• Treatment with rituximab within 6 months prior to screening
• Treatment with cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for ITP within 3 months prior to screening, with the exception of steroid sparing adjunctive treatment with cyclosporine or azathioprine
• Treatment with intravenous immunoglobulin (IVIG), WinRho® or other anti-RhD within 30 days prior to screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Other
Other design features
Three cohort dose escalation
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 563 0
New Zealand
State/province [1] 563 0

Funding & Sponsors
Funding source category [1] 2520 0
Commercial sector/Industry
Name [1] 2520 0
Protalex, Inc.
Country [1] 2520 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Protalex, Inc.
Address
New Hope, PA 18938
Country
United States of America
Secondary sponsor category [1] 2283 0
Commercial sector/Industry
Name [1] 2283 0
Trident Clinical Research Pty Ltd
Address [1] 2283 0
Gordon NSW 2072
Country [1] 2283 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4433 0
Canberra Hospital
Ethics committee address [1] 4433 0
Ethics committee country [1] 4433 0
Australia
Date submitted for ethics approval [1] 4433 0
31/07/2007
Approval date [1] 4433 0
Ethics approval number [1] 4433 0
Ethics committee name [2] 4434 0
Freemantle Hospital
Ethics committee address [2] 4434 0
Ethics committee country [2] 4434 0
Australia
Date submitted for ethics approval [2] 4434 0
21/08/2007
Approval date [2] 4434 0
Ethics approval number [2] 4434 0
Ethics committee name [3] 4435 0
Royal Brisbane
Ethics committee address [3] 4435 0
Ethics committee country [3] 4435 0
Australia
Date submitted for ethics approval [3] 4435 0
30/08/2007
Approval date [3] 4435 0
Ethics approval number [3] 4435 0
Ethics committee name [4] 4436 0
St. George Hospital
Ethics committee address [4] 4436 0
Ethics committee country [4] 4436 0
Australia
Date submitted for ethics approval [4] 4436 0
03/09/2007
Approval date [4] 4436 0
Ethics approval number [4] 4436 0
Ethics committee name [5] 5142 0
Monash Medical Centre
Ethics committee address [5] 5142 0
Ethics committee country [5] 5142 0
Australia
Date submitted for ethics approval [5] 5142 0
24/10/2007
Approval date [5] 5142 0
Ethics approval number [5] 5142 0
New ethics HREC. Please modify.
Ethics committee name [6] 5143 0
Royal Perth
Ethics committee address [6] 5143 0
Ethics committee country [6] 5143 0
Australia
Date submitted for ethics approval [6] 5143 0
03/09/2007
Approval date [6] 5143 0
Ethics approval number [6] 5143 0
New ethics HREC. Please modify.
Ethics committee name [7] 5144 0
Middlemore Hospital
Ethics committee address [7] 5144 0
Ethics committee country [7] 5144 0
New Zealand
Date submitted for ethics approval [7] 5144 0
26/10/2007
Approval date [7] 5144 0
Ethics approval number [7] 5144 0
New ethics HREC. Please modify.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27991 0
Address 27991 0
Country 27991 0
Phone 27991 0
Fax 27991 0
Email 27991 0
Contact person for public queries
Name 11148 0
Anissa Leh, MS
Address 11148 0
Protalex, Inc. 145 Union Square, New Hope, PA 18938
Country 11148 0
United States of America
Phone 11148 0
+1 215 862 9720
Fax 11148 0
Email 11148 0
aleh@protalex.com
Contact person for scientific queries
Name 2076 0
Edward Bernton, MD
Address 2076 0
Protalex, Inc.
145 Union Square
New Hope, PA 18938
Country 2076 0
United States of America
Phone 2076 0
+1 215-862-9720
Fax 2076 0
Email 2076 0
ebernton@protalex.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.