Trial · NCT01290601
Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults
NCT01290601, Phase 2, Terminated, U.S. Army Medical Research and Development Command; results first posted 2018-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults. Trials, record NCT01290601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01290601
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults
- NCT number
- NCT01290601
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Conditions
- Malaria, Plasmodium Vivax
- Interventions
- Tafenoquine, Chloroquine + Primaquine, tafenoquine, Chloroquine + Primaquine
- First posted
- 2011-02-07
- Last updated
- 2018-02-23
- Results first posted
- 2018-01-25
- Limitations and caveats
IDMC determined that Cohort 1 failed to meet specified endpoint for d28 cure rate; Cohort 2 wasn't initiated and follow-up in Cohort 1 should be completed according to protocol. Following last subjects last visit for Cohort 1 study was terminated.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate | 28 Days | A subject will be considered a success (cure) if they have an Adequate Clinical Response (ACR). Tafenoquine was efficacious if the lower bound of the two-sided 90% confidence interval for the day 28 cure rate was not less than 85% |
| Secondary | Number of Subjects Without Relapse of P. Vivax | Day 28, Months 2, 3 and 4 | Number of subjects without relapse of P. vivax at 2, 3 and 4 months \- Blood smears were obtained at Days 28, 60, 90 and 120 to confirm the continued absence of P. vivax parasitemia |
| Secondary | Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs) | 90 Days | To evaluate the safety and tolerability of the tafenoquine dosing regimens as defined by the most common AE's overall, occurring in \>10% of subjects in either treatment group |
| Secondary | Parasite and Gametocyte Clearance Time (PCT and GCT) | up to day 7 after baseline smear | Serial blood smears to detect the presence of P. vivax parasites and gametocytes, conducted every 12 hours up to and including day 7, until blood smear became negative were utilized to determine the time to clearance. PCT and GCT were considered cleared if 2 consecutive blood smears were negative. |
| Other | Fever Clearance Time (FCT) | through day 7 | Measure of body temperature every 12 hours through day 7 was used to determine the time (to nearest 12 hours) from initiation of treatment until subjects temperature decreased to 37.2C and remained at or below that level for a minimum of 24 hours. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate | 28 Days | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Without Relapse of P. Vivax | Day 28, Months 2, 3 and 4 | Intent to treat population | participants | NUMBER |
| SECONDARY | Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs) | 90 Days | AEs | NUMBER | |
| SECONDARY | Parasite and Gametocyte Clearance Time (PCT and GCT) | up to day 7 after baseline smear | Intent to treat population | Hours | MEAN |
| OTHER_PRE_SPECIFIED | Fever Clearance Time (FCT) | through day 7 | Intent to treat population | Hours | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate | Cohort 1 Tafenoquine | Adequate Clinical Response (ACR) | 40 | Participants | |
| Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate | Cohort 1-Chloroquine | Adequate Clinical Response (ACR) | 22 | Participants | |
| Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate | Cohort 1 Tafenoquine | Early Treatment Failure | 5 | Participants | |
| Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate | Cohort 1-Chloroquine | Early Treatment Failure | 0 | Participants | |
| Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate | Cohort 1 Tafenoquine | Late Treatment Failure | 1 | Participants | |
| Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate | Cohort 1-Chloroquine | Late Treatment Failure | 2 | Participants | |
| Number of Subjects Without Relapse of P. Vivax | Cohort 1 Tafenoquine | Cleared at Day 28 | 40 | participants | |
| Number of Subjects Without Relapse of P. Vivax | Cohort 1-Chloroquine | Cleared at Day 28 | 22 | participants | |
| Number of Subjects Without Relapse of P. Vivax | Cohort 1 Tafenoquine | Relapsed by Day 60 | 0 | participants | |
| Number of Subjects Without Relapse of P. Vivax | Cohort 1-Chloroquine | Relapsed by Day 60 | 0 | participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 Tafenoquine | 46 | |
| Overall Study | STARTED | Cohort 1-Chloroquine | 24 | |
| Overall Study | STARTED | Cohort 2 Tafenoquine | 0 | |
| Overall Study | STARTED | Cohort 2 Chloroquine | 0 | |
| Overall Study | COMPLETED | Cohort 1 Tafenoquine | 35 | |
| Overall Study | COMPLETED | Cohort 1-Chloroquine | 19 | |
| Overall Study | COMPLETED | Cohort 2 Tafenoquine | 0 | |
| Overall Study | COMPLETED | Cohort 2 Chloroquine | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 Tafenoquine | 11 | |
| Overall Study | NOT COMPLETED | Cohort 1-Chloroquine | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events202
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 | Eosinophilia | Blood and lymphatic system disorders | Cohort 1 Tafenoquine | 8 | 46 | 8 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 1-Chloroquine | 7 | 24 | 7 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1 Tafenoquine | 6 | 46 | 6 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1-Chloroquine | 0 | 24 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 1 Tafenoquine | 2 | 46 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 1-Chloroquine | 0 | 24 | 0 |
| other | Acquired methaemoglobinaemia | Blood and lymphatic system disorders | Cohort 1 Tafenoquine | 1 | 46 | 1 |
| other | Acquired methaemoglobinaemia | Blood and lymphatic system disorders | Cohort 1-Chloroquine | 0 | 24 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 1 Tafenoquine | 1 | 46 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 1-Chloroquine | 0 | 24 | 0 |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 Tafenoquine | 0 | 46 |
| Total, all-cause mortality | Cohort 1-Chloroquine | 0 | 24 |
| Total, other adverse events | Cohort 1 Tafenoquine | 46 | 46 |
| Total, other adverse events | Cohort 1-Chloroquine | 22 | 24 |
| Total, serious adverse events | Cohort 1 Tafenoquine | 5 | 46 |
| Total, serious adverse events | Cohort 1-Chloroquine | 0 | 24 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 Tafenoquine vs Cohort 1-Chloroquine: deaths from any cause | Trial comparisons |
| Cohort 1 Tafenoquine vs Cohort 1-Chloroquine: 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/NCT01290601
GET https://conductscience.org/api/trials/v1/NCT01290601/results?page=2