- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01860989
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study.
cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
|
KAE609 75mg single dose
KAE609 150mg single dose
KAE609 225mg single dose
KAE609 300mg single dose
|
Experimental: Cohort 2
6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose
|
KAE609 75mg single dose
KAE609 150mg single dose
KAE609 225mg single dose
KAE609 300mg single dose
|
Experimental: Cohort 3
6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose
|
KAE609 75mg single dose
KAE609 150mg single dose
KAE609 225mg single dose
KAE609 300mg single dose
|
Experimental: Cohort4
6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose
|
KAE609 75mg single dose
KAE609 150mg single dose
KAE609 225mg single dose
KAE609 300mg single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28-day Cure Rate
Time Frame: Day 28
|
28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29.
The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).
|
Day 28
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CKAE609X2202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cure Rate
-
Shanghai Jiao Tong University School of MedicineCompletedCure Rate of Helicobacter Pylori InfectionChina
-
Philips Clinical & Medical Affairs GlobalNot yet recruitingHeart Rate | Respiration Rate
-
ContinUse Biometrics Ltd.CompletedHeart Rate | Respiratory RateIsrael
-
University Hospital Southampton NHS Foundation...University of SouthamptonCompletedExercise | Heart Rate | Respiratory RateUnited Kingdom
-
Assaf-Harofeh Medical CenterUnknown
-
KK Women's and Children's HospitalRenew GroupCompletedHeart Rate | Respiratory Rate | Vital SignSingapore
-
KK Women's and Children's HospitalRenew GroupActive, not recruitingHeart Rate | Respiratory Rate | Vital SignSingapore
-
University Health Network, TorontoCompletedVital Signs Monitoring | Blood Pressure, Heart Rate, Respiratory Rate, Heart Rate Variability, Stress Index, Vital Signs MonitoringCanada
-
Florida State UniversityCompletedHeart Rate Variability | Appetite | Resting Metabolic RateUnited States
-
MX LABS spółka z ograniczoną odpowiedzialnością...CompletedHeart Rate Variability | Heart Rate | Respiratory RatePoland
Clinical Trials on KAE609
-
Novartis PharmaceuticalsCompleted
-
Novartis PharmaceuticalsWellcome TrustCompleted
-
Novartis PharmaceuticalsCompleted
-
Novartis PharmaceuticalsMedicine for Malaria VentureTerminatedPlasmodium Falciparum MalariaAustralia
-
Novartis PharmaceuticalsRecruitingUncomplicated Plasmodium Falciparum MalariaCôte D'Ivoire, Kenya, Ghana, Uganda
-
Novartis PharmaceuticalsSupported by Wellcome Trust via Grant # Grant Number 207813/Z/17/ZCompletedMalariaGabon, Ghana, Mali, Rwanda, Uganda
-
Novartis PharmaceuticalsWellcome Trust; European and Developing Countries Clinical Trials Partnership...RecruitingSevere MalariaBurkina Faso, India, Rwanda, Congo, The Democratic Republic of the, Gabon, Nigeria, Côte D'Ivoire, Kenya, Uganda
-
Central South UniversityRecruitingCommon Mental DisorderChina