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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT01860989
Date of registration:	21/05/2013
Prospective Registration:	Yes
Primary sponsor:	Novartis Pharmaceuticals
Public title:	A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
Scientific title:	An Open Label, Single Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum Malaria Mono-infection
Date of first enrolment:	July 2013
Target sample size:	11
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01860989
Study type:	Interventional
Study design:
Phase:	Phase 2

Countries of recruitment
Mali	Taiwan	Thailand	Vietnam

Contacts

Name:	Novartis Pharmaceuticals
Address:
Telephone:
Email:
Affiliation:	Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female patients aged 20 to 60 years

- Presence of mono-infection of P. falciparum

- Weight between 40 kg to 90 kg

Exclusion Criteria:

- Patients with signs and symptoms of severe/complicated malaria

- Mixed Plasmodium infection

- Presence of other serious or chronic clinical condition requiring hospitalization.

- Severe malnutrition

- Significant chronic medical conditions which in the opinion of the investigator
preclude enrollment into the study

Age minimum: 20 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cure Rate

Intervention(s)

Drug: KAE609

Primary Outcome(s)

28-day Cure Rate [Time Frame: Day 28]

Secondary Outcome(s)

Secondary ID(s)

CKAE609X2202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	03/09/2015
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01860989

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