Phase 2
N=11
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
Cure Rate
Bottom Line
View on ClinicalTrials.gov: NCT01860989 ↗Enrolled (actual)
11
Serious AEs
27.3%
Results posted
Sep 2015
Primary outcome: Primary: 28-day Cure Rate — 63.67 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KAE609 (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 28-day Cure Rate |
63.67 | — |
Summary
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01860989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.