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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00500032 |
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Date of registration:
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11/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers
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Scientific title:
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Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers Who Completed Study 6108A1-500 |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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87 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00500032 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Australia
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Australia: medinfo@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
1. Completed study 6108A1-500.
2. Hemoglobin level =12.0 and =16.5 g/dL for female subjects and =13.0 and =18.5 g/dL
for male subjects.
3. Body weight =45 and =120 kg.
4. Systolic blood pressure >90 and <180 mm Hg.
5. Diastolic blood pressure >60 and <100 mm Hg.
6. Able to be contacted by telephone.
7. For all female subjects: have a negative urine pregnancy test unless the subject is
surgically sterile.
Main Exclusion Criteria:
1. Bleeding diathesis or condition associated with prolonged bleeding time.
2. Prior antibiotic use (within 14 days).
3. Any clinically significant chronic disease that, in the investigator's judgment may
be worsened by blood draw.
Age minimum:
18 Years
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Procedure: blood draw
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Primary Outcome(s)
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Primary objective is to obtain blood volumes (approximately 200 to 470 mL per bleed) from volunteer donors who previously completed study 6108A1-500, for use in serological assay development.
[Time Frame: 1 Year]
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Secondary ID(s)
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6108A1-1000
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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