The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
A single dose of TQ will be administered orally on Day 1 or Day 2.
A single dose of PQ will be administered orally, daily, on Day 1 or 2 to Day 14 (or Day 15 if PQ started on Day 2).
A single dose of CQ will be administered orally, daily, on Days 1 to 3.
GSK Investigational Site
Ahmedabad, India
RECRUITINGGSK Investigational Site
Kolkata, India
RECRUITINGGSK Investigational Site
Mumbai, India
RECRUITINGNumber of participants remaining recurrence-free during the 6 months post-treatment and have a negative blood smear at the Month 6 (end of study [EOS]) visit
Two consecutive negative blood smears between Day 2 and Day 8, no positive blood smear for P. vivax parasites at any point during the 6-month follow-up period, and a negative P. vivax smear at the 6-month assessment.
Time frame: Up to Month 6
Number of participants with clinically relevant hemolysis change from baseline
A decrease in hemoglobin of greater than or equal to (\>=) 30% or greater than (\>) 3g/deciliter (dL) from baseline; or an overall drop in hemoglobin below 6.0 g/dL or complications thereof (e.g., required transfusions, acute renal failure) are considered clinically relevant hemolysis changes.
Time frame: Up to Day 14
Time to recurrence of P. vivax malaria
Recurrence is defined as a positive blood smear for P. vivax parasites within the 6-month follow-up period, after clearance of blood-stage parasitemia.
Time frame: Up to Month 6
Number of participants with treatment emergent adverse events (TEAEs) up to Month 6
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Month 6
Number of participants with TEAEs meeting >= Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 criteria
Severity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening, Grade 5-Death.
Time frame: Up to Month 6
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GSK Investigational Site
Surat, India
RECRUITINGNumber of participants with drug related TEAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Month 6
Number of participants with serious AEs (SAEs)
A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
Time frame: Up to Month 6
Number of participants with AEs resulting in treatment discontinuation
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Month 6
Number of participants with AEs leading to study withdrawal
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Month 6
Number of participants with AEs considered to be hematologically related
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Month 6
Number of deaths
Time frame: Up to Month 6
Liver chemistry changes meeting Hy's criteria
Hy's criteria cases were defined as any elevated alanine aminotransferase (ALT) \>=3 times upper limit of normal (ULN) and total bilirubin \>=2 times ULN or ALT \>=3 times ULN and international normalized ratio (INR) \>1.5.
Time frame: Up to Month 6
Laboratory parameters meeting >= Division of AIDS (DAIDs) Grade 3 criteria
Time frame: Up to Month 6
Vital sign parameters meeting >=DAIDs Grade 3 criteria
Time frame: Up to Month 6
Number of participants with TEAEs up to Week 4
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Week 4
Change from baseline at each study visit for clinical chemistry parameters (ALT, AST, ALP)
Data for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) is measured in international units/liter (IU/L).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (CPK)
Data for creatine phosphokinase (CPK) is measured in units per liter (U/L).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (total bilirubin, indirect bilirubin, blood urea nitrogen [BUN]/Urea, and serum creatinine)
Clinical chemistry parameters are measured in milligrams per decilitre (mg/dL).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (serum electrolytes)
Data for serum electrolytes is measured in millimoles per liter (mmol/L).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (platelet count)
Platelets are measured in number of platelets per microliter (µL).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (red blood cell [RBC] count)
Data for RBC is measured in millions of cells per microliter (number of RBCs x10\^6/µL).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (mean corpuscular volume [MCV])
Data for MVC is measured in femtoliters (fL).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (mean corpuscular hemoglobin [MCH])
Data for MCH is measured in picograms (pg) per cell.
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (percentage of reticulocytes)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (white blood cell count [WBC] with differential)
Data for neutrophils, lymphocytes, monocytes, eosinophils and basophils is presented as a count, which measures a percentage (%) of the WBC.
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (hemoglobin)
Hemoglobin is measured in grams per deciliter (g/dL).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (hematocrit)
Hematocrit is measured in volume percentage (%) of RBC in blood.
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180