Trial · NCT02802501
Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria
NCT02802501, Phase 3, Completed, GlaxoSmithKline; results first posted 2020-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria. Trials, record NCT02802501. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02802501
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria
- NCT number
- NCT02802501
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Malaria, Vivax
- Interventions
- Tafenoquine, Matched-Placebo for Tafenoquine, Primaquine, Matched-Placebo for Primaquine, Dihydroartemisinin-piperaquine (DHA-PQP), ACT plus PQ (Rescue medication), PQ (End of study treatment)
- First posted
- 2016-06-16
- Last updated
- 2020-07-24
- Results first posted
- 2020-07-24
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Tafenoquine With DHA-PQP and DHA-PQP Alone | 6 months post-dose | A participant was considered to have demonstrated relapse-free efficacy at 6 months if: a) Participant had non-zero Plasmodium vivax (P.vivax) asexual parasite count at Baseline (Day 1), b) Participant demonstrated 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 180 following initial parasite clearance, d) Participants did not take a concomitant medication with anti-malarial activity (excluding study treatment) at any point between Study Day 1 and their last parasite assessment, e) Participant was parasite-free at 6 months. The percentage of participants who were relapse-free at 6 months post dose has been presented. |
| Secondary | Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Tafenoquine With DHA-PQP and Primaquine+DHA-PQP | 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 (Day 1), b) Participant demonstrated 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 180 following initial parasite clearance, d) Participants did not take a concomitant medication with anti-malarial activity (excluding study treatment) at any point between Study Day 1 and their last parasite assessment, e) Participant was parasite-free at 6 months. The percentage of participants who were relapse-free at 6 months post dose has been presented. |
| Secondary | Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Primaquine With DHA-PQP and DHA-PQP Alone | 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 (Day 1), b) Participant demonstrated 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 180 following initial parasite clearance, d) Participants did not take a concomitant medication with anti-malarial activity (excluding study treatment) at any point between Study Day 1 and their last parasite assessment, e) Participant was parasite-free at 6 months. The percentage of participants who were relapse-free at 6 months post dose has been presented. |
| Secondary | Percentage of Participants With Relapse-free Efficacy at Four Months After Administration of Tafenoquine With DHA-PQP and DHA-PQP Alone | 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 demonstrated 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 135 following initial parasite clearance, d) Participants did not take a concomitant medication with anti-malarial activity (excluding study treatment) at any point between Study Day 1 and their first parasite assessment after Study Day 105 (up to and including Study Day 135), e) Participant was 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. |
| 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 P. vivax malaria after clearance of the initial infection. The time to relapse (number of days between the date of first positive count and date of Study Day 1) was analyzed by the Kaplan-Meier method. The median number of days to relapse along with 95 percent (%) confidence interval (CI) has been presented for each treatment group. |
| Secondary | Time to Fever Clearance | Up to Day 7 | Time to fever clearance is defined as time from first dose of treatment to the time when body temperature falls to normal and remains normal for at least 48 hours up to the Day 7 visit. Fever clearance is considered to have been achieved once an initial temperature of greater than 37.4 degree Celsius is reduced to a value less than or equal to 37.4 degree Celsius, in the absence of value greater than 37.4 degree Celsius in the following 48 hours up to Day 7 visit. The time taken to achieve fever clearance was analyzed by Kaplan-Meier method. |
| Secondary | Time to Parasite Clearance | Up to Day 8 | 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 hours later. The time to achieve parasite clearance was analyzed by Kaplan-Meier method. |
| Secondary | Number of Participants With Recrudescence | Up to Day 14 | Recrudescence was defined as blood stage treatment failure. A participant was considered to have had a recrudescence if both of the following were true: 1) if participant had a positive P. vivax asexual parasite count at Baseline and demonstrated clearance (i.e. two negative asexual P. vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval); 2) Participant had a positive genetically homologous asexual P. vivax parasite count on or before Study Day 14, after their zero count in days 1 to 5. |
| Secondary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Double-blind Treatment Phase | Up to Day 180 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as 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, is associated with liver injury and impaired liver function, other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. |
| Secondary | Number of Participants With Chemistry Values Outside Clinical Concern Range | Up to Day 120 | Blood samples were collected at indicated time points to analyze following chemistry parameters: alanine aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin, Creatine Kinase, Creatinine, Indirect Bilirubin and Urea. Clinical concern range for the parameters included ALT and AST (high: \>3 times Upper Limit of Normal \[ULN\]), ALP (high: \>2.5 times ULN), bilirubin and indirect bilirubin (high: \>1.5 times ULN), creatine kinase (high: \>5 times ULN), creatinine (high: \>3 times ULN) and urea (high: \>11.067 millimoles per Liter \[mmol/L\]. Data for any time on treatment has been presented. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
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 Relapse-free Efficacy at Six Months After Administration of Tafenoquine With DHA-PQP and DHA-PQP Alone | 6 months post-dose | Microbiologic Intent-to-Treat (mITT) Population consisted of all randomized participants who received at least one dose of blinded study treatment and had microscopically confirmed P. vivax parasitamia at Baseline. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Tafenoquine With DHA-PQP and Primaquine+DHA-PQP | 6 months post-dose | mITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Primaquine With DHA-PQP and DHA-PQP Alone | 6 months post-dose | mITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Relapse-free Efficacy at Four Months After Administration of Tafenoquine With DHA-PQP and DHA-PQP Alone | 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 Fever Clearance | Up to Day 7 | mITT Population. | Hours | MEDIAN |
| SECONDARY | Time to Parasite Clearance | Up to Day 8 | mITT Population. | Hours | MEDIAN |
| SECONDARY | Number of Participants With Recrudescence | Up to Day 14 | mITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Double-blind Treatment Phase | Up to Day 180 | Safety Population consisted of all randomized participants who received at least one dose of blinded study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Chemistry Values Outside Clinical Concern Range | Up to Day 120 | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group221
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 Relapse-free Efficacy at Six Months After Administration of Tafenoquine With DHA-PQP and DHA-PQP Alone | DHA-PQP Only | 12 | Percentage of participants | ||
| Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Tafenoquine With DHA-PQP and DHA-PQP Alone | Tafenoquine+ DHA-PQP | 22 | Percentage of participants | ||
| Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Tafenoquine With DHA-PQP and Primaquine+DHA-PQP | Tafenoquine+ DHA-PQP | 22 | Percentage of participants | ||
| Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Tafenoquine With DHA-PQP and Primaquine+DHA-PQP | Primaquine+DHA-PQP | 52 | Percentage of participants | ||
| Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Primaquine With DHA-PQP and DHA-PQP Alone | DHA-PQP Only | 12 | Percentage of participants | ||
| Percentage of Participants With Relapse-free Efficacy at Six Months After Administration of Primaquine With DHA-PQP and DHA-PQP Alone | Primaquine+DHA-PQP | 52 | Percentage of participants | ||
| Percentage of Participants With Relapse-free Efficacy at Four Months After Administration of Tafenoquine With DHA-PQP and DHA-PQP Alone | DHA-PQP Only | 16 | Percentage of participants | ||
| Percentage of Participants With Relapse-free Efficacy at Four Months After Administration of Tafenoquine With DHA-PQP and DHA-PQP Alone | Tafenoquine+ DHA-PQP | 28 | Percentage of participants | ||
| Time to Relapse of P. Vivax Malaria | DHA-PQP Only | 81.5 | 95% Confidence Interval 74.0 to 88.0 | Days | |
| Time to Relapse of P. Vivax Malaria | Tafenoquine+ DHA-PQP | 96.0 | 95% Confidence Interval 88.0 to 117.0 | Days |
1 to 10 of 221Source ClinicalTrials.gov
See all 221 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind (Up to Day 180) | STARTED | DHA-PQP Only | 50 | |
| Double-blind (Up to Day 180) | STARTED | Tafenoquine+ DHA-PQP | 50 | |
| Double-blind (Up to Day 180) | STARTED | Primaquine+DHA-PQP | 50 | |
| Double-blind (Up to Day 180) | COMPLETED | DHA-PQP Only | 50 | |
| Double-blind (Up to Day 180) | COMPLETED | Tafenoquine+ DHA-PQP | 50 | |
| Double-blind (Up to Day 180) | COMPLETED | Primaquine+DHA-PQP | 50 | |
| Double-blind (Up to Day 180) | NOT COMPLETED | DHA-PQP Only | 0 | |
| Double-blind (Up to Day 180) | NOT COMPLETED | Tafenoquine+ DHA-PQP | 0 | |
| Double-blind (Up to Day 180) | NOT COMPLETED | Primaquine+DHA-PQP | 0 | |
| Open-Label (Day 180 to Day 195) | STARTED | DHA-PQP Only | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events126
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 | Upper respiratory tract infection | Infections and infestations | DHA-PQP Only | 7 | 50 | 7 |
| other | Upper respiratory tract infection | Infections and infestations | Tafenoquine+ DHA-PQP | 11 | 50 | 13 |
| other | Upper respiratory tract infection | Infections and infestations | Primaquine+DHA-PQP | 8 | 50 | 8 |
| other | Upper respiratory tract infection | Infections and infestations | DHA-PQP Only (Open-label Primaquine Phase) | 0 | 6 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | Tafenoquine 300 mg+DHA-PQP (Open-label Primaquine Phase) | 0 | 12 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | Primaquine 15 mg+DHA-PQP (Open-label Primaquine Phase) | 0 | 26 | 0 |
| other | Nasopharyngitis | Infections and infestations | DHA-PQP Only | 7 | 50 | 8 |
| other | Nasopharyngitis | Infections and infestations | Tafenoquine+ DHA-PQP | 5 | 50 | 6 |
| other | Nasopharyngitis | Infections and infestations | Primaquine+DHA-PQP | 2 | 50 | 2 |
| other | Nasopharyngitis | Infections and infestations | DHA-PQP Only (Open-label Primaquine Phase) | 0 | 6 | 0 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DHA-PQP Only | 0 | 50 |
| Total, all-cause mortality | Tafenoquine+ DHA-PQP | 0 | 50 |
| Total, all-cause mortality | Primaquine+DHA-PQP | 0 | 50 |
| Total, all-cause mortality | DHA-PQP Only (Open-label Primaquine Phase) | 0 | 6 |
| Total, all-cause mortality | Tafenoquine 300 mg+DHA-PQP (Open-label Primaquine Phase) | 0 | 12 |
| Total, all-cause mortality | Primaquine 15 mg+DHA-PQP (Open-label Primaquine Phase) | 0 | 26 |
| Total, other adverse events | DHA-PQP Only | 32 | 50 |
| Total, other adverse events | Tafenoquine+ DHA-PQP | 36 | 50 |
| Total, other adverse events | Primaquine+DHA-PQP | 27 | 50 |
| Total, other adverse events | DHA-PQP Only (Open-label Primaquine Phase) | 0 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37236221 | 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/NCT02802501
GET https://conductscience.org/api/trials/v1/NCT02802501/registered?page=2