A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection

Phase 2

Completed

• Conditions: Cure Rate
• Interventions: Drug: KAE609

• Registration Number: NCT01860989
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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

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 Timeline

• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Study Start: 2013-07
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-08-05
• Results First Submitted QC: 2015-08-05
• Status Verified: 2015-09
• Results First Posted: 2015-09-03
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	KAE609	6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose
Cohort 3	KAE609	6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose
Cohort4	KAE609	6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose
Cohort 1	KAE609	6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose

Primary Outcome Measures

Name	Time	Method
28-day Cure Rate	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).

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇳 Hanoi, Vietnam