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

Cure Rate Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860989
• Other study ID #: CKAE609X2202
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2013
• Last updated: September 8, 2015
• Start date: July 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public HealthVietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cure Rate

Intervention

Drug:
• KAE609
KAE609 75mg single dose
• KAE609
KAE609 150mg single dose
• KAE609
KAE609 225mg single dose
• KAE609
KAE609 300mg single dose

Locations

Country	Name	City	State
Thailand	Novartis Investigative Site	Ratchabari
Thailand	Novartis Investigative Site	Srisaket
Thailand	Novartis Investigative Site	Tak
Vietnam	Novartis Investigative Site	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day Cure Rate	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	No