Trial · NCT02563496
A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria
NCT02563496, Phase 2, Completed, GlaxoSmithKline; results first posted 2020-11-02
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria. Trials, record NCT02563496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02563496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria
- NCT number
- NCT02563496
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Malaria, Vivax
- Interventions
- Tafenoquine, Chloroquine
- First posted
- 2015-09-30
- Last updated
- 2020-11-02
- Results first posted
- 2020-11-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve From Time 0 Extrapolated to Infinite Time (AUC[0-infinity]) of Tafenoquine by Weight Band in Participants Aged >=2 Years to <16 Years (Weighing >=5 kg) | Days 3, 15, 29 and 60 post dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of tafenoquine. Pharmacokinetic parameters were determined using standard non-compartmental methods. AUC(0-infinity) of tafenoquine was evaluated for participants aged \>=2 years to \<16 years (weighing \>=5 kg). Pharmacokinetic (PK) population consisted of all participants with at least one PK sample taken at Days 3, 15, 29 and 60, with accurate dosing and sample time histories. |
| Secondary | Number of Participants With Gastrointestinal Adverse Events | Up to Day 120 | Number of participants experiencing gastrointestinal adverse events including vomiting, abdominal pain, diarrhea, gastrointestinal disorder, epigastric discomfort and nausea were assessed. Number of participants with gastrointestinal adverse events for each treatment group have been presented. Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). |
| Secondary | Number of Participants With Hemoglobin Decline From Baseline Over First 10 Days | Baseline and up to Day 10 | Glucose-6-phosphate dehydrogenase (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 decrease of \>=30 percent (%) of \>30 grams per liter (g/L) from Baseline; or, an overall drop in hemoglobin below 60.0 g/L in the first 15 days of the study were considered as protocol defined serious adverse events (SAEs). Number of participants with hemoglobin decline from Baseline over first 10 days have been presented. Baseline was defined as the latest pre-tafenoquine dose assessment on Day 1. |
| Secondary | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Up to Day 120 | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. An 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 liver injury. |
| Secondary | Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Baseline (Day 1) and up to Day 8 | Blood samples were collected for analysis of eosinophils, lymphocytes, platelets and reticulocytes. PCI ranges were \>1.5\*10\^9 (high) cells per liter (cells/L) for eosinophils, \<0.5\*10\^9 cells/L (low) or \>4\*10\^9 cells/L (high) for lymphocytes, \<50\*10\^9 cells/L (low) for platelet count and \>1\*upper limit of normal (ULN) 10\^12 cells/L (high) for reticulocyte count. Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in "To within Range or No Change" category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Baseline value is the latest pre-tafenoquine dose assessment on Day 1. |
| Secondary | Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Baseline (Day 1) and up to Day 8 | Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were \>3\*ULN international units per liter (IU/L) (alanine aminotransferase \[ALT\]), \>2.5\*ULN IU/L (alkaline phosphatase), \>3\*ULN IU/L (aspartate aminotransferase \[AST\]), \>1.5\*ULN micromoles/L (mcmol/L) (bilirubin), \>5\*ULN IU/L (creatine kinase \[CK\]), 3\*ULN mcmol/L (creatinine), \>1.5\*ULN mcmol/L (indirect bilirubin), and \>11.067 millimoles/L (urea). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category. Participants were counted twice if participant has values that changed "To Low and To High", so the percentages may not add to 100%. Baseline value is the latest pre-Tafenoquine dose assessment on Day 1. |
| Secondary | Number of Participants With Relapse-Free Efficacy at 4 Months | 4 months | Relapse is defined as positive blood smear with or without vivax malaria symptoms. A participant was considered to have demonstrated relapse-free efficacy if: a) Participant is slide positive for Plasmodium vivax (P. vivax) at Baseline. b) Participant showed initial clearance of P. vivax parasitemia defined as a negative slide at or before the Day 29 visit. c) Participant is not slide-positive for P. vivax at any assessment. 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 4 months defined as a negative asexual P. vivax parasite slide at the first parasite assessment performed during study. Microbiologic-Intent-To-Treat (mITT) Population consisted of all participants who received a dose of study treatment (tafenoquine) and had microscopically-confirmed vivax parasitemia at Baseline. |
| Secondary | AUC(0-infinity) of Tafenoquine by Weight Band in Participants Aged >=6 Months to <2 Years (Weighing >=5 kg) | Days 3, 15, 29 and 60 post dose | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tafenoquine. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve From Time 0 Extrapolated to Infinite Time (AUC[0-infinity]) of Tafenoquine by Weight Band in Participants Aged >=2 Years to <16 Years (Weighing >=5 kg) | Days 3, 15, 29 and 60 post dose | PK Population. | Hours*microgram per milliliter | MEDIAN |
| SECONDARY | Number of Participants With Gastrointestinal Adverse Events | Up to Day 120 | Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hemoglobin Decline From Baseline Over First 10 Days | Baseline and up to Day 10 | Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Up to Day 120 | Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Baseline (Day 1) and up to Day 8 | Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Baseline (Day 1) and up to Day 8 | Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Relapse-Free Efficacy at 4 Months | 4 months | mITT Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | AUC(0-infinity) of Tafenoquine by Weight Band in Participants Aged >=6 Months to <2 Years (Weighing >=5 kg) | Days 3, 15, 29 and 60 post dose | PK Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. |
Source ClinicalTrials.gov
Results by group196
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve From Time 0 Extrapolated to Infinite Time (AUC[0-infinity]) of Tafenoquine by Weight Band in Participants Aged >=2 Years to <16 Years (Weighing >=5 kg) | Tafenoquine 100 mg | 85.1 | Full Range 47.1 to 116.2 | Hours*microgram per milliliter | |
| Area Under the Curve From Time 0 Extrapolated to Infinite Time (AUC[0-infinity]) of Tafenoquine by Weight Band in Participants Aged >=2 Years to <16 Years (Weighing >=5 kg) | Tafenoquine 150 mg | 154.7 | Full Range 107.4 to 247.1 | Hours*microgram per milliliter | |
| Area Under the Curve From Time 0 Extrapolated to Infinite Time (AUC[0-infinity]) of Tafenoquine by Weight Band in Participants Aged >=2 Years to <16 Years (Weighing >=5 kg) | Tafenoquine 200 mg | 111.4 | Full Range 73.8 to 143.0 | Hours*microgram per milliliter | |
| Area Under the Curve From Time 0 Extrapolated to Infinite Time (AUC[0-infinity]) of Tafenoquine by Weight Band in Participants Aged >=2 Years to <16 Years (Weighing >=5 kg) | Tafenoquine 300 mg | 120.8 | Full Range 36.1 to 181.2 | Hours*microgram per milliliter | |
| Number of Participants With Gastrointestinal Adverse Events | Tafenoquine 100 mg | Vomiting | 2 | Participants | |
| Number of Participants With Gastrointestinal Adverse Events | Tafenoquine 150 mg | Vomiting | 3 | Participants | |
| Number of Participants With Gastrointestinal Adverse Events | Tafenoquine 200 mg | Vomiting | 1 | Participants | |
| Number of Participants With Gastrointestinal Adverse Events | Tafenoquine 300 mg | Vomiting | 6 | Participants | |
| Number of Participants With Gastrointestinal Adverse Events | Tafenoquine 100 mg | Abdominal pain | 0 | Participants | |
| Number of Participants With Gastrointestinal Adverse Events | Tafenoquine 150 mg | Abdominal pain | 0 | Participants |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tafenoquine 50 mg | 0 | |
| Overall Study | STARTED | Tafenoquine 100 mg | 14 | |
| Overall Study | STARTED | Tafenoquine 150 mg | 5 | |
| Overall Study | STARTED | Tafenoquine 200 mg | 22 | |
| Overall Study | STARTED | Tafenoquine 300 mg | 19 | |
| Overall Study | COMPLETED | Tafenoquine 50 mg | 0 | |
| Overall Study | COMPLETED | Tafenoquine 100 mg | 14 | |
| Overall Study | COMPLETED | Tafenoquine 150 mg | 5 | |
| Overall Study | COMPLETED | Tafenoquine 200 mg | 22 | |
| Overall Study | COMPLETED | Tafenoquine 300 mg | 19 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events150
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Tafenoquine 50 mg | 0 | 0 | |
| other | Vomiting | Gastrointestinal disorders | Tafenoquine 100 mg | 2 | 14 | |
| other | Vomiting | Gastrointestinal disorders | Tafenoquine 150 mg | 3 | 5 | |
| other | Vomiting | Gastrointestinal disorders | Tafenoquine 200 mg | 1 | 22 | |
| other | Vomiting | Gastrointestinal disorders | Tafenoquine 300 mg | 6 | 19 | |
| other | Pyrexia | General disorders | Tafenoquine 50 mg | 0 | 0 | |
| other | Pyrexia | General disorders | Tafenoquine 100 mg | 2 | 14 | |
| other | Pyrexia | General disorders | Tafenoquine 150 mg | 0 | 5 | |
| other | Pyrexia | General disorders | Tafenoquine 200 mg | 5 | 22 | |
| other | Pyrexia | General disorders | Tafenoquine 300 mg | 1 | 19 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tafenoquine 50 mg | 0 | 0 |
| Total, all-cause mortality | Tafenoquine 100 mg | 0 | 14 |
| Total, all-cause mortality | Tafenoquine 150 mg | 0 | 5 |
| Total, all-cause mortality | Tafenoquine 200 mg | 0 | 22 |
| Total, all-cause mortality | Tafenoquine 300 mg | 0 | 19 |
| Total, other adverse events | Tafenoquine 50 mg | 0 | 0 |
| Total, other adverse events | Tafenoquine 100 mg | 10 | 14 |
| Total, other adverse events | Tafenoquine 150 mg | 4 | 5 |
| Total, other adverse events | Tafenoquine 200 mg | 10 | 22 |
| Total, other adverse events | Tafenoquine 300 mg | 13 | 19 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34871570 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02563496
GET https://conductscience.org/api/trials/v1/NCT02563496/results?page=2