Trial · NCT01376167
Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse
NCT01376167, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse. Trials, record NCT01376167. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01376167
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse
- NCT number
- NCT01376167
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 851 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Malaria, Vivax
- Interventions
Chloroquine 600mg, Chloroquine 300mg, Tafenoquine 50mg, Tafenoquine 100mg, Tafenoquine 300mg, Tafenoquine 600mg, Primaquine 15mg, Chloroquine 600mg (Part 2 ), Chloroquine 300mg (Part 2 ), Tafenoquine 300mg (Part 2), Primaquine 15mg (Part2 )
- First posted
- 2011-06-20
- Last updated
- 2018-04-23
- Results first posted
- 2018-04-23
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose | 6 months post dose | 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. |
| Secondary | Number of Participants With Recurrence-free Efficacy at 4 Months Post Dose | 4 months post dose | 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. |
| Secondary | Time to Recurrence of P Vivax Malaria | Up to Day 180 | 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. |
| Secondary | Time to Parasite Clearance | Up to Day 180 | 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. |
| Secondary | Time to Fever Clearance | Up to Day 180 | 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. |
| Secondary | Number of Participants With Hemoglobin Decline From Baseline Over First 29 Days | Baseline and up to Day 29 | 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Potentially Related to Hemoglobin Decrease | Up to Day 180 | 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. |
| Secondary | Number of Participants Who Received Blood Transfusion | Up to Day 180 | The number of participants who received blood transfusion as a result of hemoglobin decline has been summarized. |
| Secondary | Number of Participants With Acute Renal Failure | Up to Day 180 | There were no participants with acute renal failure in the study. |
| Secondary | Change From Baseline in Percent Methemoglobin | Baseline and up to Day 120 | 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. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose | 6 months post dose | Microbiologic intent to treat (mITT) Population-all randomized participants who received at least one dose of study medication, who have at least one P vivax parasite assessment after randomization, and who have a positive parasite smear for P vivax at Baseline. | Participants | NUMBER |
| SECONDARY | Number of Participants With Recurrence-free Efficacy at 4 Months Post Dose | 4 months post dose | mITT Population | Participants | NUMBER |
| SECONDARY | Time to Recurrence 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 180 | mITT Population | Hours | MEDIAN |
| SECONDARY | Number of Participants With Hemoglobin Decline From Baseline Over First 29 Days | Baseline and up to Day 29 | Safety Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Potentially Related to Hemoglobin Decrease | Up to Day 180 | Safety Population | Participants | NUMBER |
| SECONDARY | Number of Participants Who Received Blood Transfusion | Up to Day 180 | Safety Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Acute Renal Failure | Up to Day 180 | Safety Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Percent Methemoglobin | Baseline and up to Day 120 | Safety Population | Percent Methemoglobin | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group371
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose | CQ Only | 35 | Participants | ||
| Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose | TQ + CQ | 155 | Participants | ||
| Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose | PQ + CQ | 83 | Participants | ||
| Number of Participants With Recurrence-free Efficacy at 4 Months Post Dose | CQ Only | 47 | Participants | ||
| Number of Participants With Recurrence-free Efficacy at 4 Months Post Dose | TQ + CQ | 177 | Participants | ||
| Number of Participants With Recurrence-free Efficacy at 4 Months Post Dose | PQ + CQ | 90 | Participants | ||
| Time to Recurrence of P Vivax Malaria | CQ Only | 86 | 95% Confidence Interval 63 to 109 | Days | |
| Time to Recurrence of P Vivax Malaria | TQ + CQ | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Recurrence of P Vivax Malaria | PQ + CQ | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Parasite Clearance | CQ Only | 43 | 95% Confidence Interval 41 to 48 | Hours |
1 to 10 of 371Source ClinicalTrials.gov
See all 371 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CQ Only | 133 | |
| Overall Study | STARTED | TQ + CQ | 260 | |
| Overall Study | STARTED | PQ + CQ | 129 | |
| Overall Study | COMPLETED | CQ Only | 129 | |
| Overall Study | COMPLETED | TQ + CQ | 250 | |
| Overall Study | COMPLETED | PQ + CQ | 123 | |
| Overall Study | NOT COMPLETED | CQ Only | 4 | |
| Overall Study | NOT COMPLETED | TQ + CQ | 10 | |
| Overall Study | NOT COMPLETED | PQ + CQ | 6 |
Source ClinicalTrials.gov
Adverse events75
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 | Nausea | Gastrointestinal disorders | CQ Only | 12 | 133 | 13 |
| other | Nausea | Gastrointestinal disorders | TQ + CQ | 21 | 260 | 22 |
| other | Nausea | Gastrointestinal disorders | PQ + CQ | 8 | 129 | 8 |
| other | Vomiting | Gastrointestinal disorders | CQ Only | 9 | 133 | 10 |
| other | Vomiting | Gastrointestinal disorders | TQ + CQ | 22 | 260 | 22 |
| other | Vomiting | Gastrointestinal disorders | PQ + CQ | 10 | 129 | 10 |
| other | Abdominal pain upper | Gastrointestinal disorders | CQ Only | 13 | 133 | 13 |
| other | Abdominal pain upper | Gastrointestinal disorders | TQ + CQ | 11 | 260 | 14 |
| other | Abdominal pain upper | Gastrointestinal disorders | PQ + CQ | 7 | 129 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | CQ Only | 6 | 133 | 6 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CQ Only | 0 | 133 |
| Total, all-cause mortality | TQ + CQ | 0 | 260 |
| Total, all-cause mortality | PQ + CQ | 0 | 129 |
| Total, other adverse events | CQ Only | 72 | 133 |
| Total, other adverse events | TQ + CQ | 119 | 260 |
| Total, other adverse events | PQ + CQ | 56 | 129 |
| Total, serious adverse events | CQ Only | 6 | 133 |
| Total, serious adverse events | TQ + CQ | 21 | 260 |
| Total, serious adverse events | PQ + CQ | 4 | 129 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT01376167
GET https://conductscience.org/api/trials/v1/NCT01376167/registered?page=2