A study to establish Laboratory Normal Range for G6PD enzyme levels
Phase 1
- Registration Number
- CTRI/2011/12/002242
- Lead Sponsor
- GlaxoSmithKline Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 324
Inclusion Criteria
1. The subject is between 18 and 45 years of age, inclusive,
2. The subject is male,
3. The subject has a Hgb concentration ≥12g/dL
4. The subject has a reticulocyte count ≤ 2.5%
5. A signed and dated informed consent is obtained from the subject or the subject?s
legal representative prior to screening.
Exclusion Criteria
History of haemoglobinopathy (e.g. sickle cell disease, hereditary spherocytosis,
thalassaemias, haemoglobin M/E, etc.); past or current history of
methaemoglobinaemia or methaemoglobin percentage above 3%
2. Past medical history of G6PD deficiency
3. Any other co-morbidity or treatment that, in the opinion of the investigator, might
influence haematopoiesis
4. Any person that may have donated blood in the last 56 days
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish a normal range for non G6PD deficient males in laboratories being used to <br/ ><br>screen patients in study TAF112582Timepoint: 2 months
- Secondary Outcome Measures
Name Time Method Secondary objective is to assess the intra-laboratory variability of the G6PD quantitative <br/ ><br>enzyme assay.Timepoint: 2 months