Trial Outcomes & Findings for A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection (NCT NCT01860989)
NCT ID: NCT01860989
Last Updated: 2015-09-10
Results Overview
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).
COMPLETED
PHASE2
11 participants
Day 28
2015-09-10
Participant Flow
Participant milestones
| Measure |
Total - Cohort 1
Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Total - Cohort 1
Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
|
|---|---|
|
Overall Study
Unsatisfactory therapeutic
|
5
|
Baseline Characteristics
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
Baseline characteristics by cohort
| Measure |
Total - Cohort 1
n=11 Participants
Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
|
|---|---|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 7.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: PharmacoDynamic (PD) Analysis Set - All the 11 patients were included in PD analysis set.
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).
Outcome measures
| Measure |
Total - Cohort 1
n=11 Participants
Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
|
|---|---|
|
28-day Cure Rate
|
63.67 Percentage of participants
|
Adverse Events
Total - Cohort 1
Serious adverse events
| Measure |
Total - Cohort 1
n=11 participants at risk
Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
|
|---|---|
|
Hepatobiliary disorders
Jaundice
|
9.1%
1/11
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
2/11
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11
|
Other adverse events
| Measure |
Total - Cohort 1
n=11 participants at risk
Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
1/11
|
|
Cardiac disorders
Bradycardia
|
9.1%
1/11
|
|
Cardiac disorders
Sinus bradycardia
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
1/11
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11
|
|
Gastrointestinal disorders
Nausea
|
27.3%
3/11
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11
|
|
General disorders
Fatigue
|
18.2%
2/11
|
|
General disorders
Pyrexia
|
9.1%
1/11
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11
|
|
Investigations
Alanine aminotransferase increased
|
45.5%
5/11
|
|
Investigations
Aspartate aminotransferase increased
|
36.4%
4/11
|
|
Investigations
Blood alkaline phosphatase increased
|
18.2%
2/11
|
|
Investigations
Blood pressure systolic increased
|
9.1%
1/11
|
|
Investigations
Electrocardiogram QT prolonged
|
9.1%
1/11
|
|
Investigations
Platelet count decreased
|
63.6%
7/11
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.4%
4/11
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11
|
|
Nervous system disorders
Headache
|
27.3%
3/11
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
1/11
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER