Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201801002894101
• Date of registration: 20/12/2017
• Prospective Registration: No
• Primary sponsor: Novartis Pharma AG
• Public title: Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
• Scientific title: A Phase 2, multi-center, randomized, open-label, dose escalation study to determine safety of single (QD) and multiple (3 QD) doses of KAE609, given to adults with uncomplicated Plasmodium falciparum malaria
• Date of first enrolment: 13/11/2017
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2894
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a randomisation table created by a computer software program,Central randomisation by phone/fax
• Phase: Phase-2

Countries of recruitment

Mali

Contacts

• Name: Preetam Gandhi
• Affiliation: Medical Director

• Name: Preetam Gandhi
• Affiliation: Medical Director

Key inclusion & exclusion criteria

Inclusion criteria: ¿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.

Exclusion criteria: ¿ 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:
o AST/ALT > 1.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
o AST/ALT > 1.0 and ¿ 1.5 x ULN and total bilirubin is > ULN
o 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).


Age minimum: 18 Year(s)
Age maximum: 100 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria

Malaria

Intervention(s)

Cohort 4: Treatment arm 10. KAE 609

Active comparator treatment arm 2: coartem control

Cohort 3: Treatment arm 7

Cohort 3: Treatment arm 8

Cohort 4: Treatment arm 9: KAE609

Cohort 2: Treatment arm 4 - KAE609 10mg

Cohort 4: Treatment arm 11. Coartem

Cohort 1_Treatment arm 1 KAE609

Cohort 2: Treatment arm 4

Cohort 3: Treamtent arm 6 KAE609 50mg QD

Treatment arm 3: KAE609 25 mg SD

Primary Outcome(s)

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(s)

Fever clearance time

Time after administration of a drug when the maximum plasma concentrations is reached (Tmax)

Maximum Peak Observed Concentration (Cmax)

Proportion of patients with parasitaemia

Half-life (T½)

Polymerase Chain Reaction (PCR) corrected Clinical and Parasitological Cure

Area under the curve (AUC)

Parasite Clearance Time

Recrudescence

Uncorrected Adequate Clinical and Parasitological Response

Secondary ID(s)

NCT03334747

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 08/08/2017
Contact:

Faculty of Medicine, Pharmacy and Odontostomatology Ethics Committee