Assessing a Risk Model for G6PD Deficiency

• Status: Terminated
• Trial end date: 2018-10-21
• Target enrollment: 0
• Participant gender: All

Summary

A clinical study designed to develop and inform an individual risk of hemolysis model based on individual red blood cell G6PD levels. Volunteers who are eligible to treatment with primaquine as per national guidelines and with confirmed normal G6PD levels as per the fluorescent spot test will be exposed to treatment regimens of either primaquine alone for 14 days or 3 day chloroquine with concomitant primaquine for 14 days. The volunteers will be followed intensively during treatment and for 14 days after treatment for haematologic measures, G6PD quantification, and drug level assays.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PATH
• Collaborator: Mahidol Oxford Tropical Medicine Research Unit
• Treatments: Chloroquine; Chloroquine diphosphate; Primaquine

Criteria

Inclusion Criteria:

• Previous G6PD test at Shoklo Malaria Research Unit (SMRU) clinic with one of following results: 1) G6PD homozygous wildtype females (G6PD genotype normal) 2) G6PD heterozygous females with a normal FST (G6PD genotype abnormal with G6PD activity ≥40% and ≤80% of normal ) 3) G6PD hemizygous wildtype males (G6PD genotype normal)

• Willing to participate and sign informed consent form

• Willing to allow donated samples to be used in future research

• Aged ≥18 years

• Ability (in the investigators' opinion) and willing to comply with all study requirements

Exclusion Criteria:

All participants:

• Malaria or other illness

• Recent history (within 20 days) of anti-malarial treatment

• History of allergy or adverse reaction to chloroquine or primaquine

• Blood transfusion in the past 3 months

• G6PD activity less than 40% normal activity or 3.00 IU/gHb by the quantitative G6PD spectrophotometric assay

• Haemoglobin ≤10 g/dL

• Presence of any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study

Female participants only:

• Pregnancy at the time of screening

• Breastfeeding