At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 43 enrolled
Drug / intervention
KAF156drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Proof-of-concept, Open Label Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
In Brief
A Phase 2 clinical trial evaluating KAF156 for Malaria. Completed, enrolled 43 participants across 5 sites in 2 countries.
Detailed Summary
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400 mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesThailand, Vietnam
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartMar 2013
Primary CompletionAug 2014
TodayJul 2026
First PostedDec 20, 2012
Enrollment StartMar 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.5 years ago
Interventions
KAF156drug
KAF156 was supplied as tablets for oral use.