Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
- Conditions
- Malaria
- Registration Number
- PACTR201801002894101
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
¿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/¿L.
¿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.
¿Mixed Plasmodiun 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:
oAST/ALT > 1.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
oAST/ALT > 1.0 and ¿ 1.5 x ULN and total bilirubin is > ULN
oTotal 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At least 2 CTCAE grades increase from baseline in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) during the 4 week study period ¿ 2 Grade (CTCAE grades) increase from baseline (at any time point during the study)
- Secondary Outcome Measures
Name Time Method Recrudescence ;Polymerase Chain Reaction (PCR) corrected Clinical and Parasitological Cure ;Parasite Clearance Time ;Proportion of patients with parasitaemia ;Maximum Peak Observed Concentration (Cmax);Area under the curve (AUC) ;Time after administration of a drug when the maximum plasma concentrations is reached (Tmax) ;Half-life (T½);Fever clearance time;Uncorrected Adequate Clinical and Parasitological Response