Status:
TERMINATED
Assessing a Risk Model for G6PD Deficiency
Lead Sponsor:
PATH
Collaborating Sponsors:
Mahidol Oxford Tropical Medicine Research Unit
Conditions:
Malaria, Vivax
G6PD Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 na...
Detailed Description
Open label, randomized trial with 72 total participants assigned to one of two treatment arms. Each arm will have 36 participants comprised of 12 males hemizygous for wildtype G6PD, 12 females homozyg...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03337152
Start Date
May 7 2018
End Date
October 21 2018
Last Update
November 12 2021
Active Locations (1)
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1
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Thailand