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Study protocol CKAF156X2201: A proof-of-concept, open label study to assess efficacy, safety, tolerability and pharmacokinetics of KAF156 in adult patients with acute, uncomplicated Plasmodium falciparum or vivax malaria mono-infection

Leong, Franz Joel Wen and Zhao, Rong and Magnusson, Baldur (2016) Study protocol CKAF156X2201: A proof-of-concept, open label study to assess efficacy, safety, tolerability and pharmacokinetics of KAF156 in adult patients with acute, uncomplicated Plasmodium falciparum or vivax malaria mono-infection. New England journal of medicine : NEJM., 375 (12). pp. 1152-1160. ISSN 0028-4793

Abstract

This is a redacted study protocol (CKAF156X2201) for inclusion with our manuscript 'The novel imidazolopiperazine KAF156 clears parasitemia rapidly in falciparum and vivax malaria', currently being reviewed by the New England Journal of Medicine for publication. The original manuscript was approved through OAK (07 Jan 2016 Article 28035). The New England Journal has requested inclusion of the study protocol with our manuscript, and will publish the protocol online under the supplementary materials section associated with the manuscript. There is precedent for this - the KAE609X2201 protocol was published with redactions in the same journal in 2014, following review and approval by NIBR legal and patents. Consequently, Richard Janovjak (NITD legal) has been added as a reviewer at the request of Priya Mannum. We have redacted personal names and information of people not associated with the this publication, as well as the sections on biomarkers and pharmacogenomics, and most of the exploratory objectives, except for those mentioned in the manuscript.

Item Type: Article
Date Deposited: 12 Oct 2016 00:45
Last Modified: 12 Oct 2016 00:45
URI: https://oak.novartis.com/id/eprint/29288

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