Trial · NCT02216123
Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria
NCT02216123, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria. Trials, record NCT02216123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02216123
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria
- NCT number
- NCT02216123
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 251 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Malaria, Vivax
- Interventions
- Tafenoquine, Tafenoquine Placebo, Chloroquine, Primaquine, Primaquine Placebo
- First posted
- 2014-08-13
- Last updated
- 2018-05-16
- Results first posted
- 2018-05-16
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinically Relevant Hemolysis. | Up to Day 180 | Clinically relevant hemolysis is defined as a decrease in hemoglobin of \>=30% or \>3 grams per deciliter (g/dL) from Baseline; or, an overall drop in hemoglobin below 6.0 g/dL at any visit after the first dose of study medication. The percentage of participants with clinically relevant hemolysis has been summarized. Safety Population comprised of all randomized participants who received at least one dose of blinded study medication. |
| Primary | Percentage of Female Participants With Moderate Glucose-6 Phosphate Dehydrogenase (G6PD) Deficiency Experiencing Clinically Relevant Hemolysis. | Up to Day 180 | Clinically relevant hemolysis is defined as a decrease in hemoglobin of \>=30% or \>3 g/dL from Baseline; or, an overall drop in hemoglobin below 6.0 g/dL at any visit after the first dose of study medication. Despite additional efforts, no females with moderate G6PD-deficiency were enrolled that experienced clinically-significant hemolysis during the study; hence, the end point could not be estimated. |
| Secondary | Rate of Relapse-free Efficacy at Six Months Post Dose | 6 months post dose | A participant was considered to have demonstrated relapse-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. The rate of relapse-free efficacy was estimated by Kaplan-Meier methodology. The percentage of participants who were relapse-free at 6 months post dose has been presented along with 95% confidence interval. |
| Secondary | Rate of Relapse-free Efficacy at Four Months Post Dose | 4 months post dose | A participant was considered to have demonstrated recurrence-free efficacy at 4 months if: a) Participant had non-zero P. vivax asexual parasite count at Baseline. b) Participant showed initial clearance of P. vivax parasitemia. c) Participant had no positive asexual P. vivax parasite count at any assessment prior to or on Study Day 130 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 after Study Day 109 (up to and including Study Day 130). e) Participant is parasite-free at 4 months. The rate of relapse-free efficacy was estimated by Kaplan-Meier methodology. The percentage of participants who were relapse-free at 4 months post dose has been presented along with 95% confidence interval. |
| Secondary | Time to Relapse of P. Vivax Malaria | Up to Day 180 | Relapse is defined by a positive blood smear with or without vivax symptoms. Relapse is described as any recurrence of malaria that occurred after Day 32 of the study. The time to relapse was analyzed by the Kaplan-Meier method. The median number of days to relapse along with 95% confidence interval has been presented for each treatment group. |
| Secondary | Time to Parasite Clearance | Up to Day 180 | Parasite clearance time is 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 later. The time to achieve parasite clearance was analyzed by Kaplan-Meier methodology. The median parasite clearance time along with 95% confidence interval has been presented for each treatment group. |
| Secondary | Time to Fever Clearance | Up to Day 9 | Fever clearance time is defined as the 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 37.4 degree Celsius is reduced to a value less than or equal to 37.4 degree Celsius, in the absence of value more than 37.4 degree Celsius in the following 48 hours up to the Day 8 visit. The time taken to achieve fever clearance was analyzed by Kaplan-Meier method. |
| Secondary | Time to Gametocyte Clearance | Up to Day 180 | Gametocyte clearance time is defined as time from first dose until the first slide that was gametocyte negative and remained so at the next slide reading. The time taken to achieve gametocyte clearance was analyzed by Kaplan-Meier method. |
| Secondary | Number of Participants With Recrudescence | Up to Day 32 | Recrudescence is defined as any P. vivax parasitemia occurring on or before Day 32 (that is, blood stage treatment failure). A participant was considered to have had a recrudescence if both of the following were true: a) Participant had a positive P. vivax asexual parasite count at Baseline and demonstrated clearance (that is, did not have two negative asexual P. vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval). b) Participant had a positive genetically homologous asexual P. vivax parasite count, after their zero count in Days 1 to 5, but on or before Study Day 32. The number of participants with recrudescence before Study Day 33 has been presented. |
| Secondary | Number of Participants With Genetically Homologous and Genetically Heterologous P. Vivax Infections | Up to Day 180 | Two drops of peripheral blood were collected onto pre-printed filter paper for subsequent deoxyribonucleic acid (DNA) extraction and polymerase chain reaction (PCR) analysis of Plasmodium species on all participants at screening (Day 1; pre-dose) and; if necessary, at the time of the first recrudescence/relapse or re-infection. PCR of the P. vivax genes, was used to distinguish between genetically homologous and genetically heterologous infection. The number of participants with genetically homologous and genetically heterologous P. vivax infections has been summarized for each treatment group. Only those participants with an infection occuring on or after Study Day 33 were analyzed. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinically Relevant Hemolysis. | Up to Day 180 | Safety Population | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Female Participants With Moderate Glucose-6 Phosphate Dehydrogenase (G6PD) Deficiency Experiencing Clinically Relevant Hemolysis. | Up to Day 180 | Safety Population | ||
| SECONDARY | Rate of Relapse-free Efficacy at Six Months Post Dose | 6 months post dose | Microbiologic-Intent-To-Treat (mITT) Population comprised of all randomized participants who received at least one dose of blinded study medication and had microscopically-confimed P. vivax parasitemia at Baseline. | Percentage of participants | NUMBER |
| SECONDARY | Rate of Relapse-free Efficacy at Four Months Post Dose | 4 months post dose | mITT Population | Percentage of participants | NUMBER |
| SECONDARY | Time to Relapse of P. Vivax Malaria | Up to Day 180 | mITT Population | Days | MEDIAN |
| SECONDARY | Time to Parasite Clearance | Up to Day 180 | mITT Population | Hours | MEDIAN |
| SECONDARY | Time to Fever Clearance | Up to Day 9 | mITT Population | Hours | MEDIAN |
| SECONDARY | Time to Gametocyte Clearance | Up to Day 180 | mITT Population | Hours | MEDIAN |
| SECONDARY | Number of Participants With Recrudescence | Up to Day 32 | mITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Genetically Homologous and Genetically Heterologous P. Vivax Infections | Up to Day 180 | mITT Population. Only those participants who had a recurrence of infection were included in the analysis. | Participants | NUMBER |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group922
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinically Relevant Hemolysis. | TQ+CQ | 2.41 | 95% Confidence Interval 0.941 to 6.031 | Percentage of participants | |
| Percentage of Participants With Clinically Relevant Hemolysis. | PQ+CQ | 1.18 | 95% Confidence Interval 0.208 to 6.367 | Percentage of participants | |
| Rate of Relapse-free Efficacy at Six Months Post Dose | TQ+CQ | 72.7 | 95% Confidence Interval 64.8 to 79.2 | Percentage of participants | |
| Rate of Relapse-free Efficacy at Six Months Post Dose | PQ+CQ | 75.1 | 95% Confidence Interval 64.2 to 83.2 | Percentage of participants | |
| Rate of Relapse-free Efficacy at Four Months Post Dose | TQ+CQ | 82.3 | 95% Confidence Interval 74.9 to 87.7 | Percentage of participants | |
| Rate of Relapse-free Efficacy at Four Months Post Dose | PQ+CQ | 79.7 | 95% Confidence Interval 68.9 to 87.1 | Percentage of participants | |
| Time to Relapse of P. Vivax Malaria | TQ+CQ | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Relapse of P. Vivax Malaria | PQ+CQ | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Parasite Clearance | TQ+CQ | 41 | 95% Confidence Interval 38 to 45 | Hours | |
| Time to Parasite Clearance | PQ+CQ | 44 | 95% Confidence Interval 41 to 49 | Hours |
1 to 10 of 922Source ClinicalTrials.gov
See all 922 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TQ+CQ | 166 | |
| Overall Study | STARTED | PQ+CQ | 85 | |
| Overall Study | COMPLETED | TQ+CQ | 160 | |
| Overall Study | COMPLETED | PQ+CQ | 83 | |
| Overall Study | NOT COMPLETED | TQ+CQ | 6 | |
| Overall Study | NOT COMPLETED | PQ+CQ | 2 |
Source ClinicalTrials.gov
Adverse events34
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 | Dizziness | Nervous system disorders | TQ+CQ | 29 | 166 | 35 |
| other | Dizziness | Nervous system disorders | PQ+CQ | 16 | 85 | 22 |
| other | Headache | Nervous system disorders | TQ+CQ | 27 | 166 | 34 |
| other | Headache | Nervous system disorders | PQ+CQ | 16 | 85 | 22 |
| other | Nausea | Gastrointestinal disorders | TQ+CQ | 21 | 166 | 23 |
| other | Nausea | Gastrointestinal disorders | PQ+CQ | 7 | 85 | 12 |
| other | Vomiting | Gastrointestinal disorders | TQ+CQ | 15 | 166 | 15 |
| other | Vomiting | Gastrointestinal disorders | PQ+CQ | 8 | 85 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | TQ+CQ | 12 | 166 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | PQ+CQ | 3 | 85 | 3 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TQ+CQ | 0 | 166 |
| Total, all-cause mortality | PQ+CQ | 0 | 85 |
| Total, other adverse events | TQ+CQ | 97 | 166 |
| Total, other adverse events | PQ+CQ | 50 | 85 |
| Total, serious adverse events | TQ+CQ | 6 | 166 |
| Total, serious adverse events | PQ+CQ | 1 | 85 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30650326 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TQ+CQ vs PQ+CQ: Number of Participants With P. Falciparum | Trial comparisons |
| TQ+CQ vs PQ+CQ: Number of Participants With Recrudescence | Trial comparisons |
| TQ+CQ vs PQ+CQ: deaths from any cause | Trial comparisons |
| TQ+CQ vs PQ+CQ: serious adverse events | Trial comparisons |
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/NCT02216123
GET https://conductscience.org/api/trials/v1/NCT02216123/registered?page=2