Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02491606
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2015-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Weekly Tafenoquine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C055852', 'term': 'tafenoquine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '1998-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-12', 'studyFirstSubmitDate': '2015-06-30', 'studyFirstSubmitQcDate': '2015-07-02', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1997-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prophylactic outcome.', 'timeFrame': '13 Weeks', 'description': '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.\n\nA blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.'}], 'secondaryOutcomes': [{'measure': 'Prophylactic outcome after 7 weeks', 'timeFrame': '7 Weeks', 'description': '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.\n\nA blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.'}, {'measure': 'Prophylactic outcome after 10 weeks', 'timeFrame': '10 Weeks', 'description': '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.\n\nA blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '28495354', 'type': 'DERIVED', 'citation': 'Novitt-Moreno A, Ransom J, Dow G, Smith B, Read LT, Toovey S. Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis. Travel Med Infect Dis. 2017 May-Jun;17:19-27. doi: 10.1016/j.tmaid.2017.05.008. Epub 2017 May 8.'}]}, 'descriptionModule': {'briefSummary': 'This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy subjects (male or female)\n2. Age of 18-55 years\n3. Residing in one of the study villages of the Nyanza Province for the entire study\n\nExclusion Criteria:\n\n1. 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.\n2. Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).\n3. Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.\n4. 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.\n5. Known hypersensitivity to any study drug.\n6. Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.\n7. Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.'}, 'identificationModule': {'nctId': 'NCT02491606', 'briefTitle': 'Evaluation of Weekly Tafenoquine', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': 'Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya', 'orgStudyIdInfo': {'id': 'A-7540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Load only', 'description': 'Loading with tafenoquine 400 mg base for three days followed by placebo weekly.', 'interventionNames': ['Drug: Tafenoquine']}, {'type': 'EXPERIMENTAL', 'label': 'Low weekly dose', 'description': 'Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.', 'interventionNames': ['Drug: Tafenoquine']}, {'type': 'EXPERIMENTAL', 'label': 'High weekly dose', 'description': 'Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.', 'interventionNames': ['Drug: Tafenoquine']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Loading with placebo for 3 days followed by placebo once weekly.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tafenoquine', 'type': 'DRUG', 'description': 'Tafenoquine 200mg and 400 mg', 'armGroupLabels': ['High weekly dose', 'Load only', 'Low weekly dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'A.J Oloo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kenya Medical Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'collaborators': [{'name': 'SmithKline Beecham', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}