Last updated: 11/27/2023 07:50:19
Non-interventional United States (US) study of Krintafel safety
GSK study ID
209685
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: A study to evaluate safety, including hypersensitivity, neuropsychiatric and hematologic adverse reactions, in United States (US) patients taking Krintafel (tafenoquine) for the radical cure of Plasmodium vivax (P. vivax) malaria
Trial description: This non-interventional study will be conducted in collaboration with the United States (US) Centers for Disease Control (CDC) and Prevention. This study will evaluate safety including hypersensitivity, neuropsychiatric, and hematologic adverse reactions in US subjects taking Krintafel (tafenoquine) for the radical cure of Plasmodium vivax (P. vivax) malaria. Krintafel is approved by the US Food and Drug Administration (FDA) for the radical cure (prevention of relapse) of Plasmodium vivax in patients aged 16 and older which are receiving appropriate antimalarial therapy for acute P. vivax infection. The study will be initiated in 2019 and completed in December 2024.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects exposed to Krintafel and reporting adverse reactions
Timeframe: Up to 5 years
Number of subject exposed to Krintafel reporting adverse events by event term
Timeframe: Up to 5 years
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
250
Primary completion date:
2024-31-05
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Malaria, Vivax
Product
tafenoquine
Collaborators
Centre for Disease and Prevention domestic malaria branch
Study date(s)
June 2019 to May 2024
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
16+ years
Accepts healthy volunteers
No
- Subjects must be reported to CDC as having received Krintafel.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects must be reported to CDC as having received Krintafel.
Exclusion criteria:
- Not applicable
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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