A study to validate A Glucose-6-Phosphate Dehydrogenase enzyme assay

Not Applicable

• Conditions: Activity of G6PD enzyme in healthy male volunteers; D55.0

• Registration Number: RBR-2z5rgg
• Lead Sponsor: Fundação de Medicina Tropical do Amazonas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;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;<br>95% average;<br>Enzymatic activity average 6.26 UI/gHB

Secondary Outcome Measures

Name	Time	Method
Determine the intra-laboratory coefficient of variation of quantitative assay of G6PD enzyme;The population analysis showed that variability between tests was low (CV of 4.77%)