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A Glucose-6-Phosphate Dehydrogenase (G6PD) enzyme assay validation protocol

PHRR130102-000041

Unspecified

Unspecified

A Glucose-6-Phosphate Dehydrogenase (G6PD) enzyme assay validation protocol

This is an enzyme assay validation protocol: to validate the G6PD quantitative enzyme assay in a laboratory supporting the tafenoquine clinical studies and to assist in defining normal range values for males.

Start Date Duration in Months Target Completion Date Actual Completion Date
2014-08-11 1 2014-09-11 0000-00-00

Ongoing

Institution Classification Region LTO #
GlaxoSmithKline Philippines, Inc. Private Business NCR
Institution Amount Region
GlaxoSmithKline Philippines, Inc. N/A NCR
Name E-Mail Phone Number Postal Address
Niranjan Kulkarni niranjan.g.kulkarni@gsk.com +6328129887 GlaxoSmithKline 2266 Chino Roces Avenue Makati City 1231
Name E-Mail Phone Number Postal Address
Niranjan Kulkarni niranjan.g.kulkarni@gsk.com +6328129887 GlaxoSmithKline 2266 Chino Roces Avenue Makati City 1231
Name Expertise Affiliation
Fe Esperanza Caridad J. Espino, MD, PhD Pediatric Infectious Disease Rio Tuba Nickel Mining Corporation Hospital
Project Location Institutional Ethics Review Board
Rio Tuba Nickel Mining Corporation Hospital N/A

G6PD values of healthy male volunteers

The mean and SD of G6PD enzyme activity in G6PD normal male subjects at laboratories to be used in the tafenoquine studies.

Unspecified

Completed

  • Bangladesh
  • Brazil
  • Ethiopia
  • India
  • Peru
  • Thailand
  • Vietnam

Clinical Trial

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Unspecified

None

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% Exclusion Criteria 1. History of haemoglobinopathy (e.g. sickle cell disease, hereditary spherocytosis,thalassaemias, haemoglobin M/E, etc.); past or current history omethaemoglobinaemia 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

Observational

Unspecified

Unspecified

Non-randomized

Not Applicable

Unspecified

Not Applicable

This is an enzyme assay validation protocol: to validate the G6PD quantitative enzyme assay in a laboratory supporting the tafenoquine clinical studies and to assist in defining normal range values for males.

Phase I

36

36

Unspecified

11 Aug 2014

Utilization Utilization Info
No records found.

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