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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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REBEC |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
RBR-2z5rgg |
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Date of registration:
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22/05/2016 |
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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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A study to validate A Glucose-6-Phosphate Dehydrogenase enzyme assay
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Scientific title:
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A follow-up of validation test protocol enzyme glucose 6-phosphate dehydrogenase ( G6PD ) to study TAF112582 |
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Date of first enrolment:
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24/03/2014 |
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Target sample size:
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Recruitment status: |
Data analysis completed |
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URL:
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http://ensaiosclinicos.gov.br/rg/RBR-2z5rgg |
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Study type:
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Intervention |
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Study design:
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Interventional clinical study, one arm, open, prospective, focusing on diagnostic of a single group for healthy male volunteers to evaluate the complete blood count and enzyme G6PD activity to be used in studies with tafenoquina
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Phase:
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N/A
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Countries of recruitment
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Bangladesh
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Brazil
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Cambodia
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Colombia
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Ethiopia
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India
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Peru
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Philippines
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Thailand
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Viet Nam
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Contacts
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Name:
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Serviço de Atendimento ao Cliente
SAC |
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Address:
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Estrada dos Bandeirantes, 8464
22783-110
Rio de Janeiro
Brazil |
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Telephone:
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+55 21 21416000 |
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Email:
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sac.brasil@gsk.com |
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Affiliation:
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GlaxoSmithKline Brasil |
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Name:
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Serviço de Informação Médica
SIM |
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Address:
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Estrada dos Bandeirantes, 8464
22783-110
Rio de Janeiro
Brazil |
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Telephone:
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+55 21 21416000 |
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Email:
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sim.brasil@gsk.com |
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Affiliation:
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GlaxoSmithKline Brasil |
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Key inclusion & exclusion criteria
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Inclusion criteria: The subject is between 18 and 45 years of age, male;
Hgb concentration greater or equal than 12g/dL;
Reticulocyte count less or equal than 2.5%;
A signed and dated informed consent from the subject or the subject’s legal representative prior to screening
Exclusion criteria: History of haemoglobinopathy;
Past or current history of methaemoglobinaemia or methaemoglobin percentage above 3%;
Past medical history of G6PD deficiency; Any other co-morbidity or treatment that, in the opinion of the investigator might
influence haematopoiesis;
Any person that may have donated blood in the last 56 days
Age minimum:
18Y
Age maximum:
45Y
Gender:
M
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Health Condition(s) or Problem(s) studied
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Activity of G6PD enzyme in healthy male volunteers
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D55.0
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Intervention(s)
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Other
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E01.370.225.998.110
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Experimental group with 36 heathy male volunteers for analysis of two collecting blood samples to complete blood count and enzyme G6PD activity to be used in studies with tafenoquina
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Primary Outcome(s)
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Establish the median, mean and standard deviation of G6PD enzyme activity in male subjects with normal G6PD in laboratories to be used in studies with tafenoquine
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The primary population analysis showed that enzymatic activity ranged from 4.21 paragraph 8.14 UI/gHB with media SD(Standard Deviation) of 1.07 UI/GHB;
95% average;
Enzymatic activity average 6.26 UI/gHB
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Secondary Outcome(s)
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The population analysis showed that variability between tests was low (CV of 4.77%)
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Determine the intra-laboratory coefficient of variation of quantitative assay of G6PD enzyme
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Source(s) of Monetary Support
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GlaxoSmithKline Brasil
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Fundação de Medicina Tropical do Amazonas
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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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