MalariaPhase 2NCT01290601

Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults

A Phase 2 study testing Tafenoquine and Chloroquine + Primaquine in people with Malaria and Plasmodium Vivax, run by U.S. Army Medical Research and Development Command at 1 site in Thailand.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This Phase II study is designed to determine whether a single 600 mg dose or 400mg/day for 3 days of tafenoquine is efficacious, and well tolerated for clearing P. vivax malaria infection (blood schizontocidal and gametocytocidal activity) and preventing P. vivax relapse (hypnozoite eradication). Read more about this study

Who is it for?: Ages 20 to 60 years
Conditions the study is for: Malaria, Plasmodium Vivax
What is being tested?: Tafenoquine and Chloroquine + Primaquine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteThailand
Study dates: 15 Sep 2003to 10 Jan 2005
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Positive smear for P. vivax.
Parasite density > 500 and < 200,000/μl
Age: 20-60 years old
Willing to sign consent form
Willing to be hospitalized for 29 days and remain in a malaria free region for 60 days thereafter for follow-up.
A female is eligible to enter and participate in this study if she is of:
a non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post-menopausal or, b child-bearing potential, has a negative pregnancy (urine or serum) test at screen, and agrees to comply with recognized contraceptive methods during the treatment stage of the study and for a period of 12 weeks after stopping study drug. Recognized contraceptive methods include, abstinence, implants of levonorgestrel, injectable progestogen, or appropriate double barrier methods using licensed contraceptives such as diaphragm and condom (by the partner) or intrauterine device and condom. The use of oral/patch contraceptives during the study is not considered sufficient contraceptive protection.

Who cannot join

Mixed malaria infections by Field's stain.
Female subjects who are pregnant, lactating or unwilling/unable to comply with recognized contraceptive methods during the treatment stage of the study and for a period of 12 weeks after stopping study drug.
Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
Demonstrated glucose-6-phosphate dehydrogenase deficiency.
Subject has taken other anti-malarials (mefloquine, primaquine, chloroquine) within the past 30 days by history
Clinically significant illness (intercurrent illness e.g. pneumonia, pre-existing condition e.g. renal disease, malignancy or conditions that may affect absorption of study medication e.g. severe diarrhea or any signs of malnutrition as defined clinically).

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Clinically significant abnormal laboratory values as determined by history, physical examination or routine blood chemistries and hematology values (laboratory guideline values for exclusion are hemoglobin <7 gm/dL, platelets < 50,000/μl, White Blood Cell count (WBC) < 2000/μl, serum creatinine >2.0mg/dL, or ALT or AST more than 3 times the upper limit of normal for age.
History of allergy to chloroquine, mefloquine, tafenoquine, primaquine or any other 8-aminoquinolines.
Subject has taken another investigational drug within 30 days or 5 half lives (whichever is longer), of study start.
History of previous eye surgery or have evidence of corneal or retinal abnormalities identified in baseline ophthalmological examination.
Subjects taking concomitant medications likely to affect renal or ophthalmic function or that are known to be metabolized primarily by the cytochrome P450 isoforms 3A4/5 and 2C9 and whose therapeutic effect occurs within a narrow plasma concentration range (e.g. warfarin, ketoconazole).
Subjects whom, after examination by the study ophthalmologist, are judged to be at risk for acute angle closure glaucoma.
Females who are pre-menarchal.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Bangkok Hospital for Tropical Diseases/Mahidol University
Bangkok, 10400

Other trials in Thailand

About this study

Official title: A Randomized, Active-control, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults

Read the detailed description

This was a randomized, active-control, double-blind, double-dummy study to be conducted in 2 sequential cohorts. Cohort 1 was randomized 2:1 to receive tafenoquine, 400mg/day for 3 days, or the standard blood schizontocidal dosing regimen of chloroquine (1000mg for 2 days followed by 500mg for 1 day) followed by a standard hypnozoite eradication dosing regimen for primaquine (15mg base per day for 14 days). Cohort 2 was to be randomized 2:1 to receive a single 600mg dose of tafenoquine or the standard blood schizontocidal dosing regimen of chloroquine (1000mg for 2 days followed by 500mg for 1 day) followed by a standard hypnozoite eradication dosing regimen for primaquine (15mg base per day for 14 days).

A planned interim analysis was performed after all subjects in Cohort 1 had completed the day 28 assessment and an Independent Data Monitoring Committee (IDMC) convened to evaluate the efficacy and safety of the tafenoquine dosing regimen (400mg once per day for 3 days) used in Cohort 1. Only if the results from Cohort 1 met pre-defined efficacy and safety criteria was enrollment to begin for Cohort 2. The efficacy criterion for achieving the primary endpoint was that the lower limit of the one-sided 95% confidence interval was no less than 85%, and for safety that a review of trends in all AEs, tolerability, medical observations, methemoglobin and other lab data for all subjects indicated the dose was well tolerated.

During the IDMC review it was determined that Cohort 1 failed to meet the pre-specified endpoint for the day 28 cure rate and therefore Cohort 2 should not be initiated and follow-up in Cohort 1 should be completed according to protocol. Following last subject last visit for Cohort 1 the study was terminated.

Conditions: Malaria, Plasmodium Vivax
Being tested: Tafenoquine, Chloroquine + Primaquine
Keywords: malaria, Plasmodium vivax, adults, treatment, tafenoquine
Medical subject headings: Malaria, Malaria, Vivax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TafenoquineDrug
Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Chloroquine + PrimaquineDrug
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
tafenoquineDrug
Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.
Chloroquine + PrimaquineDrug
Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.

Study groups in NCT01290601
Study group	Role	What they receive
Cohort 1 Tafenoquine	Experimental	Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days. Receives: Drug: Tafenoquine
Cohort 1-Chloroquine	Active comparator	Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days. Receives: Drug: Chloroquine + Primaquine
Cohort 2 Tafenoquine	Experimental	Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days. Receives: Drug: tafenoquine
Cohort 2 Chloroquine	Active comparator	Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days. Receives: Drug: Chloroquine + Primaquine

What is being measured

The primary outcome is the main question the study is designed to answer.

Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate
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%
Measured: 28 Days

Secondary outcomes (3)

Number of Subjects Without Relapse of P. Vivax
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
Measured: Day 28, Months 2, 3 and 4
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
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
Measured: 90 Days
Parasite and Gametocyte Clearance Time (PCT and GCT)
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.
Measured: up to day 7 after baseline smear

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 200310 Jan 2005

First posted7 Feb 2011 (estimated)
Study start15 Sep 2003
Primary completion10 Jan 2005
Study completion10 Jan 2005

Why it stopped: Failure to meet pre-specified endpoint for the day 28 cure rate

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Only if Cohort 1 met specified endpoint criteria would Cohort 2 begin enrollment
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01290601
Sponsor's protocol ID: TQ study 058
Other IDs: A-12055
Status last verified: Jan 2018
First submitted: 3 Feb 2011
Last updated: 23 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Warrasak S, Euswas A, Fukuda MM, Ittiverakul M, Miller RS, Krudsood S, Ohrt C. Comparative ophthalmic assessment of patients receiving tafenoquine or chloroquine/primaquine in a randomized clinical trial for Plasmodium vivax malaria radical cure. Int Ophthalmol. 2019 Aug;39(8):1767-1782. doi: 10.1007/s10792-018-1003-2. Epub 2018 Sep 29.
PubMed 30269312
Fukuda MM, Krudsood S, Mohamed K, Green JA, Warrasak S, Noedl H, Euswas A, Ittiverakul M, Buathong N, Sriwichai S, Miller RS, Ohrt C. A randomized, double-blind, active-control trial to evaluate the efficacy and safety of a three day course of tafenoquine monotherapy for the treatment of Plasmodium vivax malaria. PLoS One. 2017 Nov 9;12(11):e0187376. doi: 10.1371/journal.pone.0187376. eCollection 2017.
PubMed 29121061

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Active-control, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults
ClinicalTrials.gov ID: NCT01290601
Acronym / sponsor ID: TQ study 058
Conditions: Malaria, Plasmodium Vivax
Keywords: malaria, Plasmodium vivax, adults, treatment, tafenoquine
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Failure to meet pre-specified endpoint for the day 28 cure rate
Enrolment: 70 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Collaborators: GlaxoSmithKline
Study start: 15 Sep 2003
Primary completion: 10 Jan 2005 (actual)
Study completion: 10 Jan 2005 (actual)
First posted: 7 Feb 2011 (estimated)
Results: Posted 25 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Only if Cohort 1 met specified endpoint criteria would Cohort 2 begin enrollment

Arm	Type	Receives
Cohort 1 Tafenoquine	Experimental	Drug: TafenoquineTafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
Cohort 1-Chloroquine	Active comparator	Drug: Chloroquine + PrimaquineChloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
Cohort 2 Tafenoquine	Experimental	Drug: tafenoquineTafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.
Cohort 2 Chloroquine	Active comparator	Drug: Chloroquine + PrimaquineChloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Positive smear for P. vivax.
Parasite density > 500 and < 200,000/μl
Age: 20-60 years old
Willing to sign consent form
Willing to be hospitalized for 29 days and remain in a malaria free region for 60 days thereafter for follow-up.

Key exclusion criteria (13 listed)

Mixed malaria infections by Field's stain.
Female subjects who are pregnant, lactating or unwilling/unable to comply with recognized contraceptive methods during the treatment stage of the study and for a period of 12 weeks after stopping study drug.
Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
Demonstrated glucose-6-phosphate dehydrogenase deficiency.
Subject has taken other anti-malarials (mefloquine, primaquine, chloroquine) within the past 30 days by history

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TafenoquineTafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.	Drug	Cohort 1 Tafenoquine
Chloroquine + PrimaquineChloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.	Drug	Cohort 1-Chloroquine
tafenoquineTafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.	Drug	Cohort 2 Tafenoquine
Chloroquine + PrimaquineChloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.	Drug	Cohort 2 Chloroquine

Primary outcome

Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate
Time frame: 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%

3 secondary outcomes

Number of Subjects Without Relapse of P. Vivax
Time frame: Day 28, Months 2, 3 and 4
Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)
Time frame: 90 Days
Parasite and Gametocyte Clearance Time (PCT and GCT)
Time frame: up to day 7 after baseline smear

Results and safety

Results posted to the registry on 25 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 Tafenoquine	46	35
Cohort 1-Chloroquine	24	19
Cohort 2 Tafenoquine	0	0
Cohort 2 Chloroquine	0	0

Primary outcome: Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate

Time frame: 28 Days. Count of participants. Unit: Participants

Measure	Cohort 1 Tafenoquine n = 46	Cohort 1-Chloroquine n = 24
Adequate Clinical Response (ACR)	40	22
Early Treatment Failure	5	0
Late Treatment Failure	1	2

Population analysed: Intent to treat population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 0 - 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 Tafenoquine	5 of 46 (10.9%)	46 of 46 (100%)	0 of 46
Cohort 1-Chloroquine	0 of 24 (0%)	22 of 24 (91.7%)	0 of 24

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30269312Warrasak S, Euswas A, Fukuda MM, Ittiverakul M, Miller RS, Krudsood S, Ohrt C. Comparative ophthalmic assessment of patients receiving tafenoquine or chloroquine/primaquine in a randomized clinical trial for Plasmodium vivax malaria radical cure. Int Ophthalmol. 2019 Aug;39(8):1767-1782. doi: 10.1007/s10792-018-1003-2. Epub 2018 Sep 29.
Derived from this study: PubMed 29121061Fukuda MM, Krudsood S, Mohamed K, Green JA, Warrasak S, Noedl H, Euswas A, Ittiverakul M, Buathong N, Sriwichai S, Miller RS, Ohrt C. A randomized, double-blind, active-control trial to evaluate the efficacy and safety of a three day course of tafenoquine monotherapy for the treatment of Plasmodium vivax malaria. PLoS One. 2017 Nov 9;12(11):e0187376. doi: 10.1371/journal.pone.0187376. eCollection 2017.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sornchai Looaree Suwan, MD principal investigator

Mahidol University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tafenoquine and Chloroquine + Primaquine in people with Malaria and Plasmodium Vivax, run by U.S. Army Medical Research and Development Command at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate (time frame: 28 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01290601, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.