Last updated: 12/22/2025 06:30:19
Non-interventional United States (US) study of Krintafel safety
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study 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 was conducted in collaboration with the United States (US) CDC. The study evaluated safety, including hypersensitivity, neuropsychiatric, and hematologic adverse reactions, in US participants taking Krintafel (tafenoquine) for the radical cure of P. vivax malaria. Krintafel was approved by the US Food and Drug Administration (FDA) for the radical cure (prevention of relapse) of P. vivax in participants aged 16 and older who were receiving appropriate antimalarial therapy for acute P. vivax infection. The study was 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 participants identified as those who received Krintafel (Centers for Disease Control and Prevention [CDC] malaria case surveillance data)
Timeframe: 3 June 2019 – 31 December 2024
Number of participants identified as those who received Krintafel for radical cure of P. vivax malaria (CDC malaria case surveillance data)
Timeframe: 3 June 2019 – 31 December 2024
Number of adverse events (AEs) reported in participants who received Krintafel or Tafenoquine (this refers to Tafenoquine with unknown brand name, and hereafter referred to as ‘Tafenoquine’)
Timeframe: 3 June 2019 – 31 December 2024
Number of AEs reported in participants with confirmed P. vivax malaria who received treatment with Krintafel
Timeframe: 3 June 2019 – 31 December 2024
Number of serious and fatal AEs
Timeframe: 3 June 2019 – 31 December 2024
Number of hypersensitivity, neuropsychiatric and haematologic AEs
Timeframe: 3 June 2019 – 31 December 2024
Number of participants with off-label use of Krintafel
Timeframe: 3 June 2019 – 31 December 2024
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
10
Primary completion date:
2024-31-12
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Plasmodium vivax malaria
Product
tafenoquine
Collaborators
Centers for Disease Control and Prevention
Study date(s)
June 2019 to December 2024
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
16+ years
Accepts healthy volunteers
No
- Participants had to be reported to CDC as having received Krintafel.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Participants had to be reported to CDC as having received Krintafel.
Exclusion criteria:
- Not applicable
Trial location(s)
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2024-31-12
Actual study completion date
2024-31-12
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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