Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
NCT ID: NCT03334747
Last Updated: 2021-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
188 participants
INTERVENTIONAL
2017-11-16
2019-11-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment arm 1: KAE609 10 mg Single Dose (SD)
KAE609 10 mg once daily (QD) for 1 day
KAE609
Exploration of different doses of KAE609 to establish safety profile.
Treatment arm 2:KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
KAE609
Exploration of different doses of KAE609 to establish safety profile.
Treatment arm 3:KAE609 10 mg 3 Days
KAE609 10 mg (QD) for 3 days
KAE609
Exploration of different doses of KAE609 to establish safety profile.
Treatment arm 4:KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
KAE609
Exploration of different doses of KAE609 to establish safety profile.
Treatment arm 5:KAE609 25 mg 3 Days
KAE609 25 mg once daily (QD) for 3 days
KAE609
Exploration of different doses of KAE609 to establish safety profile.
Treatment arm 6:KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
KAE609
Exploration of different doses of KAE609 to establish safety profile.
Treatment arm 7:KAE609 50 mg 3 Days
KAE609 50 mg once daily (QD) for 3 days
KAE609
Exploration of different doses of KAE609 to establish safety profile.
Treatment arm 8: KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
KAE609
Exploration of different doses of KAE609 to establish safety profile.
Treatment arm 9: Coartem Control
Coartem® control
Coartem
Control Arm
Interventions
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KAE609
Exploration of different doses of KAE609 to establish safety profile.
Coartem
Control Arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa-stained thick film.
3. P. falciparum parasitaemia of 500 to 50 000 parasites/µL.
4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
5. 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
2. Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016 criteria (WHO 2016).
3. 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.
4. Clinical or laboratory evidence of any of the following:
5. AST/ALT \> 1.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
6. AST/ALT \> 1.0 and ≤ 1.5 x ULN and total bilirubin is \> ULN
7. Total bilirubin \> 2 x ULN, regardless of the level of AST/ALT
8. History of photodermatitis/increased sensitivity to sun.
9. Pregnant or nursing (lactating) women.
10. Known disturbances of electrolyte balance, e.g. hypokalemia, hypocalcemia or hypomagnesemia.
11. Moderate to severe anemia (Hemoglobin level \<8 g/dL).
18 Years
ALL
No
Sponsors
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Wellcome Trust
OTHER
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Lambaréné, , Gabon
Novartis Investigative Site
Kintampo, , Ghana
Novartis Investigative Site
Navrango, , Ghana
Novartis Investigative Site
Bamako, , Mali
Novartis Investigative Site
Sotouba, , Mali
Novartis Investigative Site
Kigali, , Rwanda
Novartis Investigative Site
Bushenyi, , Uganda
Novartis Investigative Site
Kampala, , Uganda
Novartis Investigative Site
Tororo, , Uganda
Countries
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References
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Ndayisaba G, Yeka A, Asante KP, Grobusch MP, Karita E, Mugerwa H, Asiimwe S, Oduro A, Fofana B, Doumbia S, Jain JP, Barsainya S, Kullak-Ublick GA, Su G, Schmitt EK, Csermak K, Gandhi P, Hughes D. Hepatic safety and tolerability of cipargamin (KAE609), in adult patients with Plasmodium falciparum malaria: a randomized, phase II, controlled, dose-escalation trial in sub-Saharan Africa. Malar J. 2021 Dec 20;20(1):478. doi: 10.1186/s12936-021-04009-1.
Schmitt EK, Ndayisaba G, Yeka A, Asante KP, Grobusch MP, Karita E, Mugerwa H, Asiimwe S, Oduro A, Fofana B, Doumbia S, Su G, Csermak Renner K, Venishetty VK, Sayyed S, Straimer J, Demin I, Barsainya S, Boulton C, Gandhi P. Efficacy of Cipargamin (KAE609) in a Randomized, Phase II Dose-Escalation Study in Adults in Sub-Saharan Africa With Uncomplicated Plasmodium falciparum Malaria. Clin Infect Dis. 2022 May 30;74(10):1831-1839. doi: 10.1093/cid/ciab716.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novartisclinicaltrials.com
Other Identifiers
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207813/Z/17/Z
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CKAE609A2202
Identifier Type: -
Identifier Source: org_study_id
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