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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)
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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)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Thrombocytopenic Purpura
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Condition category
Condition code
Blood
2363
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0
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
No comparator
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Safety
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Assessment method [1]
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Timepoint [1]
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Days 0, 1,2, 7, 14, 21, 22,23,28,35,49,63,84.
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Secondary outcome [1]
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Characterize the pharamcokinetics of PRTX-100
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [2]
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Explore immunogenicity of multiple doses of PRTX-100
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Assessment method [2]
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Timepoint [2]
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Days 0 pre-dose, 14, 28, 35, 63 and 84
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Secondary outcome [3]
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Evaluate treatment effect on platelet count
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Assessment method [3]
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Timepoint [3]
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Days 28 and 35 after 1st treatment
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Three cohort dose escalation
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Phase
Phase 1
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/10/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
21
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Protalex, Inc.
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Address [1]
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New Hope, PA 18938
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Protalex, Inc.
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Address
New Hope, PA 18938
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Country
United States of America
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Trident Clinical Research Pty Ltd
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Address [1]
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Gordon NSW 2072
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Canberra Hospital
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Ethics committee address [1]
4433
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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31/07/2007
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Approval date [1]
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Ethics approval number [1]
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Ethics committee name [2]
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Freemantle Hospital
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Ethics committee address [2]
4434
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
4434
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21/08/2007
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Approval date [2]
4434
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Ethics approval number [2]
4434
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Ethics committee name [3]
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Royal Brisbane
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Ethics committee address [3]
4435
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
4435
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30/08/2007
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Approval date [3]
4435
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Ethics approval number [3]
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Ethics committee name [4]
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St. George Hospital
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Ethics committee address [4]
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Ethics committee country [4]
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Australia
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Date submitted for ethics approval [4]
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03/09/2007
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Approval date [4]
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Ethics approval number [4]
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Ethics committee name [5]
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Monash Medical Centre
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Ethics committee address [5]
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New ethics address. Please modify.
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Ethics committee country [5]
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Australia
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Date submitted for ethics approval [5]
5142
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24/10/2007
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Approval date [5]
5142
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Ethics approval number [5]
5142
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New ethics HREC. Please modify.
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Ethics committee name [6]
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Royal Perth
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Ethics committee address [6]
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New ethics address. Please modify.
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Ethics committee country [6]
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Australia
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Date submitted for ethics approval [6]
5143
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03/09/2007
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Approval date [6]
5143
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Ethics approval number [6]
5143
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New ethics HREC. Please modify.
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Ethics committee name [7]
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Middlemore Hospital
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Ethics committee address [7]
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New ethics address. Please modify.
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Ethics committee country [7]
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New Zealand
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Date submitted for ethics approval [7]
5144
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26/10/2007
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Approval date [7]
5144
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Ethics approval number [7]
5144
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New ethics HREC. Please modify.
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Summary
Brief summary
The primary objective of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100). Patients may be enrolled into 1 of 3 dose groups. A Safety Committee will review safety data through Day 28 for the first 5 patients in a dose group. Only upon the Safety Committee's approval will the next higher dose group be enrolled and dosed.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Anissa Leh, MS
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Address
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Protalex, Inc. 145 Union Square, New Hope, PA 18938
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Country
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United States of America
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Phone
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+1 215 862 9720
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Edward Bernton, MD
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Address
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Protalex, Inc.
145 Union Square
New Hope, PA 18938
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Country
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United States of America
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Phone
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+1 215-862-9720
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Fax
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Email
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[email protected]
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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.
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