Status:
COMPLETED
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Wellcome Trust
Conditions:
Malaria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational...
Eligibility Criteria
Inclusion
- KEY
- Male and female patients ≥ 18 years with a body weight ≥ 45 kg.
- Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa-stained thick film.
- P. falciparum parasitaemia of 500 to 50 000 parasites/µL.
- Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
- Written informed consent must be obtained before any study assessment is performed. If the patient is unable to write, then a witnessed consent according to local ethical standards is permitted.
- KEY
Exclusion
- Mixed Plasmodium infections.
- Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016 criteria (WHO 2016).
- Known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis B or C (testing not required), known gallbladder or bile duct disease, acute or chronic pancreatitis.
- Clinical or laboratory evidence of any of the following:
- AST/ALT \> 1.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
- AST/ALT \> 1.0 and ≤ 1.5 x ULN and total bilirubin is \> ULN
- Total bilirubin \> 2 x ULN, regardless of the level of AST/ALT
- History of photodermatitis/increased sensitivity to sun.
- Pregnant or nursing (lactating) women.
- Known disturbances of electrolyte balance, e.g. hypokalemia, hypocalcemia or hypomagnesemia.
- Moderate to severe anemia (Hemoglobin level \<8 g/dL).
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2019
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT03334747
Start Date
November 16 2017
End Date
November 23 2019
Last Update
October 11 2021
Active Locations (9)
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1
Novartis Investigative Site
Lambaréné, Gabon
2
Novartis Investigative Site
Kintampo, Ghana
3
Novartis Investigative Site
Navrango, Ghana
4
Novartis Investigative Site
Bamako, Mali