- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02491606
Evaluation of Weekly Tafenoquine
Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy subjects (male or female)
- Age of 18-55 years
- Residing in one of the study villages of the Nyanza Province for the entire study
Exclusion Criteria:
- Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.
- Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
- Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
- Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.
- Known hypersensitivity to any study drug.
- Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
- Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Load only
Loading with tafenoquine 400 mg base for three days followed by placebo weekly.
|
Tafenoquine 200mg and 400 mg
|
Experimental: Low weekly dose
Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.
|
Tafenoquine 200mg and 400 mg
|
Experimental: High weekly dose
Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.
|
Tafenoquine 200mg and 400 mg
|
Experimental: Placebo
Loading with placebo for 3 days followed by placebo once weekly.
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prophylactic outcome.
Time Frame: 13 Weeks
|
Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells. A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites. |
13 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prophylactic outcome after 7 weeks
Time Frame: 7 Weeks
|
Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells. A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites. |
7 Weeks
|
Prophylactic outcome after 10 weeks
Time Frame: 10 Weeks
|
Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells. A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites. |
10 Weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: A.J Oloo, Kenya Medical Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-7540
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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