- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01376167
Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse
A Multi-centre, Double-blind, Randomised, Parallel-group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tafenoquine (SB-252263, WR238605) in Subjects With Plasmodium Vivax Malaria.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Bandarban, Bangladesh
- GSK Investigational Site
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Amazonas
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Manaus, Amazonas, Brazil, 69040-000
- GSK Investigational Site
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Rondônia
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Porto Velho, Rondônia, Brazil, 76812-329
- GSK Investigational Site
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Oddar Meancheay Province, Cambodia
- GSK Investigational Site
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Gondar, Ethiopia
- GSK Investigational Site
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Jimma, Ethiopia
- GSK Investigational Site
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Bikaner, India
- GSK Investigational Site
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Chennai, India, 600016
- GSK Investigational Site
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Lucknow, India, 226003
- GSK Investigational Site
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Secunderabad, India, 500 003
- GSK Investigational Site
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Loreto
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Iquitos, Loreto, Peru, Iqui 01
- GSK Investigational Site
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Rio Tuba, Bataraza, Philippines, 5306
- GSK Investigational Site
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Bangkok, Thailand, 10400
- GSK Investigational Site
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Tak, Thailand, 63110
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: - Positive Giemsa smear for P. vivax
- Parasite density >100 and <200,000/μL
- ≥16 years
- A female is eligible if she is non-pregnant, nonlactating and if she is of: - non-child bearing potential defined as: post-menopausal (12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone >40 mIU/mL), pre-menopausal and has had a hysterectomy or a bilateral oophorectomy (removal of the ovaries) or a bilateral tubal ligation with medical report verification, negative pregnancy test or,
- child-bearing potential, has a negative serum pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 90 days after stopping study drug:
- Use of oral contraceptive, either combined or progestogen alone used in conjunction with double barrier method as defined below
- Use of an intrauterine device with a documented failure rate of <1% per year
- Use of depo provera injection (part 2)
- Double barrier method consisting of spermicide with either condom or diaphragm
- Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female.
- Complete abstinence from intercourse for 2 weeks prior to administration of study drug, throughout the study and for a period of 90 days after stopping study drug.
- A signed and dated informed consent is obtained from the subject or the subject's legal representative prior to screening.
NB Assent is obtained from subjects <18 years, where applicable and written or oral witnessed consent has been obtained from parent or guardian.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned.
- Willing to be hospitalized for 3 days and return to clinic for all follow-up visits including Day 180
- QTc <450 msec at screening, based on a single QTcF value at screening (part 1 only) or as an average of triplicate Electrocardiogram obtained over a brief recording period by machine or manual over-read if first is >450 msec.- Exclusion Criteria: - Mixed malaria infections (e.g. identified by Giemsa-stained smear or rapid diagnostic test)
- Severe vivax malaria as defined by World Health Organisation criteria.
- Severe vomiting (no food or inability to take food during previous 8 hours)
- Screening haemoglobin concentration <7 g/dL.
- Glucose 6-phosphate dehydrogenase deficiency, assessed by a quantitative spectrophotometric phenotype assay:
Part 1 - Males: Any subject with an enzyme level <70% of the site median value for Glucose 6-phosphate dehydrogenase normals will be excluded. Females: Those females with a screening Hb ≥ 10 g/dL will only be excluded if their enzyme level is <70% of the site median value for Glucose 6-Phosphate dehydrogenase normals. hose females with Hb ≥7 but < 10 g/dL will be excluded if an enzyme level is not > 90% of the site median value for Glucose 6-Phosphate dehydrogenase normals.
Part 2 - Any subject with enzyme level <70% of the site median value for Glucose 6-phosphate dehydrogenase normals will be excluded
- Liver function test alanine transaminase >2x Upper Limit of Normal
- Any clinically significant concurrent illness (e.g. pneumonia, septicaemia), pre-existing conditions (e.g. renal disease, malignancy), conditions that may affect absorption of study medication (e.g. vomiting or severe diarrhea) or clinical signs and symptoms of severe cardiovascular disease (e.g. uncontrolled congestive heart failure or severe coronary artery disease). These abnormalities may be identified on the screening history and physical or laboratory examination.
- Subject has taken antimalarials (e.g. ACT, mefloquine, primaquine, chloroquine) or drugs with anti-malarial activity within the past 30 days by history.
- History of allergy to chloroquine, mefloquine, tafenoquine, primaquine or to any other 4- or 8-aminoquinolines.
- Any contraindications to chloroquine or primaquine administration including a history of porphyria, psoriasis or epilepsy (please refer to chloroquine and primaquine locally approved prescribing information).
- Subject who has previously received study medication for this protocol (all parts) or has received treatment with any other investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- History of illicit drug abuse or heavy alcohol intake within 6 months of the study.
- Subjects who have taken or will likely require the use of medications from the prohibited medication list which include the following classes: Histamine-2 blockers and antacids.
- Drugs with haemolytic potential.
- Drugs known to prolong the QTc interval
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Tafenoquine 50mg
On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered.
50mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed.
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600mg Chloroquine given to each subject on Day 1 and Day2 of the trial
300mg Chloroquine given to each subject on Day 3 of the trial
single dose 50mg Tafenoquine given to subject on treatment arm 1 on Days 1 or 2
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EXPERIMENTAL: Tafenoquine 100mg
On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered.
100mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed.
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600mg Chloroquine given to each subject on Day 1 and Day2 of the trial
300mg Chloroquine given to each subject on Day 3 of the trial
single dose 100mg Tafenoquine given to subject on treatment arm 2 on Days 1 or 2
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EXPERIMENTAL: Tafenoquine 300mg
On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered.
300mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed.
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600mg Chloroquine given to each subject on Day 1 and Day2 of the trial
300mg Chloroquine given to each subject on Day 3 of the trial
single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2
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EXPERIMENTAL: Tafenoquine 600mg
On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered.
600mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed.
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600mg Chloroquine given to each subject on Day 1 and Day2 of the trial
300mg Chloroquine given to each subject on Day 3 of the trial
single dose 600mg Tafenoquine given to subject on treatment arm 4 on Days 1 or 2
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ACTIVE_COMPARATOR: Primaquine 15mg
On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered.
15mg Primaquine once daily Days 2-15.
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600mg Chloroquine given to each subject on Day 1 and Day2 of the trial
300mg Chloroquine given to each subject on Day 3 of the trial
15mg Primaquine given once daily to subject on treatment arm 5 on Days 2 to 15.
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PLACEBO_COMPARATOR: Chloroquine only
On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered.
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600mg Chloroquine given to each subject on Day 1 and Day2 of the trial
300mg Chloroquine given to each subject on Day 3 of the trial
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EXPERIMENTAL: Tafenoquine 300mg (Part 2)
On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered.
300mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed.
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600mg Chloroquine given to each subject on Day 1 and Day2 of the trial.
300mg Chloroquine given to each subject on Day 3 of the trial.
single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2.
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ACTIVE_COMPARATOR: Primaquine 15mg (Part 2)
On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered.
15mg Primaquine once daily Days 2-15
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600mg Chloroquine given to each subject on Day 1 and Day2 of the trial.
300mg Chloroquine given to each subject on Day 3 of the trial.
15mg Primaquine given once daily to subject on treatment arm 3 on Days 2 to 15.
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PLACEBO_COMPARATOR: Chloroquine only (Part 2)
On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered
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600mg Chloroquine given to each subject on Day 1 and Day2 of the trial.
300mg Chloroquine given to each subject on Day 3 of the trial.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose
Time Frame: 6 months post dose
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A participant was considered to have demonstrated recurrence-free efficacy at 6 months if: a) Participant had non-zero P vivax asexual parasite count at Baseline.
b) Participant showed initial clearance of P vivax parasitemia defined as two negative asexual P vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval.
c) Participant had no positive asexual P vivax parasite count at any assessment prior to or on Study Day 201 following initial parasite clearance.
d) Participant did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment.
e) Participant is parasite-free at 6 months.
Participants were censored if they did not have P.vivax at Baseline, or took a drug with anti-malarial action despite not having malaria parasites, or did not have a 6 month assessment.
The number of participants with recurrence-free efficacy at 6 months has been summarized.
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6 months post dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Recurrence-free Efficacy at 4 Months Post Dose
Time Frame: 4 months post dose
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A participant (par) was considered to have demonstrated recurrence-free efficacy at 4 months if: a) Par had non-zero P vivax asexual parasite count at Baseline.
b) Par showed initial clearance of P vivax parasitemia.
c) Par had no positive asexual P vivax parasite count at any assessment prior to or on Study Day 130 following initial parasite clearance.
d) Par did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment after Study Day 109 (up to and including Study Day 130).
e) Par is parasite-free at 4 months defined as a negative asexual P vivax parasite count at the first parasite assessment performed after Study Day 109 (up to and including Study Day 130).
Par were censored if they did not have P.vivax at Baseline, or took a drug with anti-malarial action despite not having malaria parasites or did not have a 4 month assessment.
The number of par with recurrence-free efficacy at 4 months has been summarized.
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4 months post dose
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Time to Recurrence of P Vivax Malaria
Time Frame: Up to Day 180
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Recurrence was defined as the first confirmed presence of P vivax asexual stage parasites after clearance of initial parasitemia following CQ treatment.
Time to recurrence was defined as the time (in days) from initial parasite clearance to recurrence.
The time to recurrence was analyzed by the Kaplan-Meier method.
NA indicates data was not available due to insufficient number of participants with events during the follow up period in the study.
The median number of days to recurrence along with 95% confidence interval has been presented for each treatment group.
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Up to Day 180
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Time to Parasite Clearance
Time Frame: Up to Day 180
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Parasite clearance time was defined as time needed to clear asexual parasite from the blood that is, parasite numbers falling below the limit of detection in the thick blood smear and remaining undetectable after 6 to 12 hours.
The time taken to achieve parasite clearance was analyzed using Kaplan Meier Methodology.
The median parasite clearance time along with 95% confidence interval has been presented for each treatment group.
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Up to Day 180
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Time to Fever Clearance
Time Frame: Up to Day 180
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Fever clearance time was defined as time from first dose of treatment to the time when body temperature falls to normal within Study Days 1-4 and remains normal for at least 48 hours up to the Day 8 visit.
Fever clearance was considered to have been achieved once an initial temperature of more than 37.40 degree Celsius is reduced to a value less than or equal to 37.40 degree Celsius and in the absence of value more than 37.40 degree Celsius in the following 48 hours up to the Day 8 visit.
The time taken to achieve fever clearance was analyzed using Kaplan Meier Methodology.
The median fever clearance time along with 95% confidence interval has been presented for each treatment group.
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Up to Day 180
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Number of Participants With Hemoglobin Decline From Baseline Over First 29 Days
Time Frame: Baseline and up to Day 29
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Glucose-6-phosphate dehydrogenase deficiency (G6PD) deficiency is known to be a risk factor for hemolysis in participants treated with 8-aminoquinolines.
Blood samples were collected for the evaluation of hemoglobin levels.
Hemoglobin decreases of >=30% or >3 grams/deciliter (g/dL) from Baseline; or, an overall drop in hemoglobin below 6.0 g/dL in the first 15 days of the study were considered as protocol defined serious adverse events (SAEs).
Number of participants with maximum hemoglobin decline from Baseline over first 29 days of study has been summarized.
Safety Population consisted of all randomized participants who received at least one dose of study medication.
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Baseline and up to Day 29
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) Potentially Related to Hemoglobin Decrease
Time Frame: Up to Day 180
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TEAEs are defined as adverse events (AEs) with an onset date and time on or after that of the start of first dose of study medication (including CQ).
The number of participants with TEAEs potentially related to hemoglobin decrease has been presented.
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Up to Day 180
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Number of Participants Who Received Blood Transfusion
Time Frame: Up to Day 180
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The number of participants who received blood transfusion as a result of hemoglobin decline has been summarized.
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Up to Day 180
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Number of Participants With Acute Renal Failure
Time Frame: Up to Day 180
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There were no participants with acute renal failure in the study.
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Up to Day 180
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Change From Baseline in Percent Methemoglobin
Time Frame: Baseline and up to Day 120
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Methemoglobin assessment was made with the aid of a non-invasive signal extraction pulse CO-Oximeter handheld machine (Masimo).
The change from Baseline in percent methemoglobin by treatment, time and sex has been summarized.
The last assessment performed prior to the first dose of study medication (CQ or randomized treatment) was considered as Baseline.
Change from Baseline was calculated as the post baseline assessment minus the Baseline assessment for percent methemoglobin.
Only those participants with data available at the specified data points were analyzed.
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Baseline and up to Day 120
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Number of Participants With Gastrointestinal Disorders
Time Frame: Up to Day 180
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Gastrointestinal tolerability was analyzed by the number of par experiencing gastrointestinal disorders such as abdominal pain, heartburn, diarrhea, constipation, nausea, and vomiting.
The number of participants with gastrointestinal disorders for each treatment group has been summarized.
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Up to Day 180
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Number of Participants With Keratopathy
Time Frame: Up to Day 180
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Ophthalmic assessments were carried out at pre-qualified sites (Manaus) prior to randomization and at Days 29 and 90 and at withdrawal.
Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities.
The last assessment performed on the day of randomization or earlier was considered Baseline.
The number of participants displaying keratopathy in each eye was summarized for each visit.
The number of participants with new keratopathy at any time post Baseline was also reported.
Ophthalmic Safety Population comprised of all participants in the Safety Population who have results from any eye assessments.
Only those participants with data available at the specified data points were analyzed.
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Up to Day 180
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Incidence of Visual Field Abnormalities Based on Best Corrected Visual Acuity Test Scores
Time Frame: Up to Day 180
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Ophthalmic assessments were carried out at pre-qualified sites (Manaus) prior to randomization and at Days 29 and 90 and at withdrawal.
Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities.
The last assessment performed on the day of randomization or earlier was considered Baseline.
Best corrected visual acuity was assessed individually for each eye.
Scores were recorded as a ratio.
The values were used to derive a logMAR score for statistical analysis where logMAR=-1x log10 (ratio score).
The mean and standard deviation of logMAR score for each treatment group has been summarized.
High scores were associated with worse vision, and low scores with better vision.
Only those participants with data available at the specified data points were analyzed.
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Up to Day 180
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Number of Participants With Retinal Changes From Baseline
Time Frame: Baseline and up to Day 180
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Ophthalmic assessments were carried out at pre-qualified sites (Manaus) prior to randomization and at Days 29 and 90 and at withdrawal.
Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities.
The last assessment performed on the day of randomization or earlier was considered Baseline.
Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment.
The number of participants with definite retinal change and questionable (ques) retinal change from Baseline was presented.
Only those participants with data available at the specified data points were analyzed.
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Baseline and up to Day 180
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Number of Participants With TEAEs and Serious TEAEs
Time Frame: Up to Day 180
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An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with possible drug induced liver injury with hyperbilirubinemia.
TEAEs is defined as AEs with an onset date and time on or after that of the start of first dose of study medication (including CQ).
Number of participants with TEAEs and serious TEAEs have been presented.
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Up to Day 180
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Number of Participants With TEAEs by Maximum Intensity
Time Frame: Up to Day 180
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An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
TEAE is defined as AEs with an onset date and time on or after that of the start of first dose of study medication (including CQ).
Number of participants with AEs based on severity has been presented.
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Up to Day 180
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Number of Participants With Hematology Laboratory Data Outside the Reference Range
Time Frame: Up to Day 120
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Blood samples were collected for the evaluation of hematology parameters including eosinophils, leukocytes, lymphocytes, neutrophils, platelets, reticulocytes and methemoglobin.
The number of participants with hematology laboratory data outside the extended normal range (F3) was presented.
The upper and lower limits for F3 range were defined by multiplying the normal range limits by different factors.
High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Only those participants with data available at the specified data points were analyzed.
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Up to Day 120
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Number of Participants With Clinical Chemistry Laboratory Data Outside the Reference Range
Time Frame: Up to Day 120
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Blood samples were collected for the evaluation of clinical chemistry parameters including Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.
Phos), Aspartate Aminotransferase (AST), bilirubin, creatine kinase, creatinine, glomerular filtration rate (GFR), indirect bilirubin and urea.
The number of participants with clinical chemistry laboratory data outside the extended normal range (F3) was presented.
The upper and lower limits for F3 range were defined by multiplying the normal range limits by different factors.
High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Only those participants with data available at the specified data points were analyzed.
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Up to Day 120
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Cost Associated With Recurrence Episode of P Vivax Malaria
Time Frame: Up to Day 180
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Health outcomes were evaluated based on the total costs spent on treatment, transport, medication and tests.
The cost was summarized according to the place at which the participant went to for care (drug shop, trial clinic, other clinic, hospital (inpatient/outpatient), traditional healer, other).
The reported costs by type and by site has been summarized.
Where costs have not been reported at a visit, the number of participants analyzed is given as 0. Only those participants with data available at the specified data points were analyzed.
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Up to Day 180
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Cost Incurred With Purchase of Medications Associated With Recurrence Episode of Malaria
Time Frame: Up to Day 180
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Health outcomes were evaluated based on the cost of medications purchased.
The reported total medication cost for paracetamol associated with recurrence episode of P vivax malaria has been reported by site.
Where costs have not been reported at a visit, the number of participants analyzed is given as 0. Medications recorded as "Other" and medications without costs are excluded from the analysis.
Only those participants with data available at the specified data points were analyzed.
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Up to Day 180
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Time Lost by Participants or Care Givers From Normal Occupation
Time Frame: Up to Day 180
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Health outcomes were evaluated based on total time lost by participants or care givers due to an episode of malaria.
The reported time lost due to recurrence episode of P vivax malaria has been summarized by category and by site.
Where categories by site have not been reported at a visit, the number of participants analyzed is given as 0. Only those participants with data available at the specified data points were analyzed.
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Up to Day 180
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Number of Participants With Action Taken to Treat Recurrence Episode of P Vivax Malaria
Time Frame: Up to Day 180
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Health outcomes were evaluated based on the actions taken by the participants to treat recurrence episode of P vivax malaria.
The reported action taken by site is summarized.
Where no action by site have been reported at a visit, the number of participants analyzed is given as 0. Only those participants with data available at the specified data points were analyzed.
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Up to Day 180
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Oral Clearance (CL/F) of TQ
Time Frame: Day 2, Day 8, Day 15, Day 29 and Day 60
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Apparent population oral clearance of TQ
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Day 2, Day 8, Day 15, Day 29 and Day 60
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Volume of Distribution (Vc/F) of TQ
Time Frame: Day 2, Day 8, Day 15, Day 29 and Day 60
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Apparent population central volume of distribution of TQ
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Day 2, Day 8, Day 15, Day 29 and Day 60
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Lacerda MVG, Llanos-Cuentas A, Krudsood S, Lon C, Saunders DL, Mohammed R, Yilma D, Batista Pereira D, Espino FEJ, Mia RZ, Chuquiyauri R, Val F, Casapia M, Monteiro WM, Brito MAM, Costa MRF, Buathong N, Noedl H, Diro E, Getie S, Wubie KM, Abdissa A, Zeynudin A, Abebe C, Tada MS, Brand F, Beck HP, Angus B, Duparc S, Kleim JP, Kellam LM, Rousell VM, Jones SW, Hardaker E, Mohamed K, Clover DD, Fletcher K, Breton JJ, Ugwuegbulam CO, Green JA, Koh GCKW. Single-Dose Tafenoquine to Prevent Relapse of Plasmodium vivax Malaria. N Engl J Med. 2019 Jan 17;380(3):215-228. doi: 10.1056/NEJMoa1710775.
- Roper DR, De la Salle B, Soni V, Fletcher K, Green JA. Abrogation of red blood cell G6PD enzyme activity through Heat treatment: development of survey material for the UK NEQAS G6PD scheme. Int J Lab Hematol. 2017 Jun;39(3):308-316. doi: 10.1111/ijlh.12627. Epub 2017 Mar 20.
- Beck HP, Wampfler R, Carter N, Koh G, Osorio L, Rueangweerayut R, Krudsood S, Lacerda MV, Llanos-Cuentas A, Duparc S, Rubio JP, Green JA. Estimation of the Antirelapse Efficacy of Tafenoquine, Using Plasmodium vivax Genotyping. J Infect Dis. 2016 Mar 1;213(5):794-9. doi: 10.1093/infdis/jiv508. Epub 2015 Oct 23.
- Tenero D, Green JA, Goyal N. Exposure-Response Analyses for Tafenoquine after Administration to Patients with Plasmodium vivax Malaria. Antimicrob Agents Chemother. 2015 Oct;59(10):6188-94. doi: 10.1128/AAC.00718-15. Epub 2015 Jul 27.
- Llanos-Cuentas A, Lacerda MV, Rueangweerayut R, Krudsood S, Gupta SK, Kochar SK, Arthur P, Chuenchom N, Mohrle JJ, Duparc S, Ugwuegbulam C, Kleim JP, Carter N, Green JA, Kellam L. Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): a multicentre, double-blind, randomised, phase 2b dose-selection study. Lancet. 2014 Mar 22;383(9922):1049-58. doi: 10.1016/S0140-6736(13)62568-4. Epub 2013 Dec 19.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Malaria, Vivax
- Physiological Effects of Drugs
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Amebicides
- Filaricides
- Antinematodal Agents
- Anthelmintics
- Chloroquine
- Chloroquine diphosphate
- Primaquine
- Tafenoquine
Other Study ID Numbers
- 112582
- TAF112582
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Informed Consent Form
Information identifier: 112582Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 112582Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 112582Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 112582Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 112582Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 112582Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Menzies School of Health ResearchInternational Centre for Diarrhoeal Disease Research, Bangladesh; Addis Ababa... and other collaboratorsCompletedMalaria | Vivax Malaria | Falciparum MalariaEthiopia, Bangladesh, Indonesia
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Menzies School of Health ResearchAga Khan University; University of Melbourne; Universitas Sumatera Utara; Ethiopian... and other collaboratorsRecruitingVivax Malaria | Malaria, Vivax | Plasmodium Vivax | Malaria RelapseCambodia, Ethiopia, Indonesia, Pakistan
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Menzies School of Health ResearchUniversity of Melbourne; Curtin University; Addis Ababa University; Fundação de... and other collaboratorsNot yet recruitingVivax MalariaBrazil, Ethiopia, Indonesia, Papua New Guinea
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University of OxfordCompleted
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London School of Hygiene and Tropical MedicineHealthNet TPOCompletedMalaria | Vivax MalariaPakistan
Clinical Trials on Chloroquine 600mg
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Spinifex Pharmaceuticals Pty LtdSyneos HealthWithdrawn
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MyMD Pharmaceuticals, Inc.CompletedFrailty | Sarcopenia | AgingUnited States
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Elif OralCompletedFatty Liver | Hypertriglyceridemia | NASH - Nonalcoholic Steatohepatitis | Familial Partial LipodystrophyUnited States
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I-Mab Biopharma HongKong LimitedCompletedActive Ulcerative ColitisChina, Taiwan, Korea, Republic of
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Yungjin Pharm. Co., Ltd.CompletedDry Eye SyndromeKorea, Republic of
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Ewha Womans UniversityCompletedHealthy Adults With Subjective Memory ComplaintsKorea, Republic of
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National Institute of Allergy and Infectious Diseases...Not yet recruitingPregnancy | HIV-1-infection | PostpartumUnited States, South Africa
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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Dompé Farmaceutici S.p.ARecruitingAcute Respiratory Distress Syndrome, AdultUnited States, Germany, Italy
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Chia Tai Tianqing Pharmaceutical Group Nanjing...RecruitingMantle Cell LymphomaChina