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CompletedNCT03334747Updated Oct 11, 2021Results posted

Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

A Phase 2 interventional study of KAE609 and Coartem in Malaria, sponsored by Novartis Pharmaceuticals. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-11.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.

02

Conditions studied

  • Malaria

Keywords

  • uncomplicated Plasmodium falciparum Malaria.
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

KEY Inclusion Criteria:

  1. Male and female patients ≥ 18 years with a body weight ≥ 45 kg.
  2. Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa-stained thick film.
  3. P. falciparum parasitaemia of 500 to 50 000 parasites/µL.
  4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
  5. Written informed consent must be obtained before any study assessment is performed. If the patient is unable to write, then a witnessed consent according to local ethical standards is permitted.

KEY Exclusion Criteria:

  1. Mixed Plasmodium infections.
  2. Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016 criteria (WHO 2016).
  3. Known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis B or C (testing not required), known gallbladder or bile duct disease, acute or chronic pancreatitis.
  4. Clinical or laboratory evidence of any of the following:
  5. AST/ALT > 1.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
  6. AST/ALT > 1.0 and ≤ 1.5 x ULN and total bilirubin is > ULN
  7. Total bilirubin > 2 x ULN, regardless of the level of AST/ALT
  8. History of photodermatitis/increased sensitivity to sun.
  9. Pregnant or nursing (lactating) women.
  10. Known disturbances of electrolyte balance, e.g. hypokalemia, hypocalcemia or hypomagnesemia.
  11. Moderate to severe anemia (Hemoglobin level \<8 g/dL).

Other protocol-defined inclusion/exclusion criteria may apply

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
188 participants (actual)

Study arms

  • Experimental
    Treatment arm 1: KAE609 10 mg Single Dose (SD)

    KAE609 10 mg once daily (QD) for 1 day

    Drug: KAE609

  • Experimental
    Treatment arm 2:KAE609 25 mg SD

    KAE609 25 mg once daily (QD) for 1 day

    Drug: KAE609

  • Experimental
    Treatment arm 3:KAE609 10 mg 3 Days

    KAE609 10 mg (QD) for 3 days

    Drug: KAE609

  • Experimental
    Treatment arm 4:KAE609 50 mg SD

    KAE609 50 mg once daily (QD) for 1 day

    Drug: KAE609

  • Experimental
    Treatment arm 5:KAE609 25 mg 3 Days

    KAE609 25 mg once daily (QD) for 3 days

    Drug: KAE609

  • Experimental
    Treatment arm 6:KAE609 75 mg SD

    KAE609 75 mg once daily (QD) for 1 day

    Drug: KAE609

  • Experimental
    Treatment arm 7:KAE609 50 mg 3 Days

    KAE609 50 mg once daily (QD) for 3 days

    Drug: KAE609

  • Experimental
    Treatment arm 8: KAE609 150 mg SD

    KAE609 150 mg once daily (QD) for 1 day

    Drug: KAE609

  • Active comparator
    Treatment arm 9: Coartem Control

    Coartem® control

    Drug: Coartem

Interventions

  • DrugKAE609

    Exploration of different doses of KAE609 to establish safety profile.

    Also known as: Cipargamin

  • DrugCoartem

    Control Arm

    Also known as: Artemether Lumefantrine

05

What researchers measure

Primary outcomes

  1. Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)

    The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee.

    Time frame: Day 29

Secondary outcomes

  1. Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29

    PCR-corrected and PCR-uncorrected were evaluated at Days 15 and 29 (i.e., 14 and 28 days post-dose). The presence of parasitaemia after 7 days due to reinfection was considered as PCR-corrected ACPR. Missing blood smear data at Day 15 visit and thereafter were not considered as responder for the visit unless there was a later blood smear test indicating no parasitaemia.

    Time frame: Day 15, Day 29

  2. Parasite Clearance Time (PCT)

    Parasite Clearance Time (PCT) is defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. In case a patient received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication.

    Time frame: Day 29

  3. Fever Clearance Time (FCT)

    Fever Clearance Time (FCT) is defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. In case a patient received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication.

    Time frame: Day 29

  4. Time to Recrudescence and Reinfection at Study Day 29

    Time to recrudescence is calculated from the date of first study medication to the date of first event. Participants without recrudescence/reinfection after Day 7 are censored at the time of treatment failure or at the time of last parasite assessment if no treatment failure occured.

    Time frame: Day 29

  5. Maximum Peak Observed Concentration (Cmax)

    Maximum Peak Observed Concentration (Cmax)

    Time frame: Day 1, Day 3

  6. Tmax

    Tmax

    Time frame: Day 1, Day 3

  7. AUC0-24

    AUC0-24

    Time frame: Day 1, Day 3

  8. Half-life (T^1/2)

    Half-life (T\^1/2)

    Time frame: Upto day 15 post dose

06

Results

Posted Sep 25, 2020

Participant flow

This study was conducted in 10 centers in 5 countries: Mali (2), Uganda (3), Ghana (2), Gabon (1), Rwanda (2).

Treatment Phase
Participant flow — Treatment Phase
MilestoneKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SDPooled Coartem Control
Started101012202220212251
Completed91012202119212251
Not completed100011000
Withdrew: Technical problems000010000
Withdrew: Subject/guardian decision100001000
Follow-Up Phase
Participant flow — Follow-Up Phase
MilestoneKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SDPooled Coartem Control
Started91012202119212251
Completed91012202119202250
Not completed000000101
Withdrew: Subject/guardian decision000000101

Outcome measures

PrimaryNumber of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)

The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee.

Time frame:
Day 29
Reported as:
Number · Percentage of Participants
Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)
Percentage of ParticipantsKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SDPooled Coartem Control
Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)11.1 (0.3 to 48.2)0 (0.0 to 30.8)0 (0.0 to 26.5)0 (0.0 to 16.8)0 (0.0 to 16.1)0 (0.0 to 17.6)0 (0.0 to 16.1)4.5 (0.1 to 22.8)3.9 (0.5 to 13.5)
Statistical analysis
  • KAE609 10 mg SD · Fisher Exact · p = 0.3912-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
  • KAE609 10 mg QD 3 Days · Fisher Exact · p = 12-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
  • KAE609 25 mg SD · Fisher Exact · p = 12-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
  • KAE609 25 mg QD 3 Days · Fisher Exact · p = 12-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
  • KAE609 50 mg SD · Fisher Exact · p = 12-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
  • KAE609 50 mg QD 3 Days · Fisher Exact · p = 12-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
  • KAE609 75 mg SD · Fisher Exact · p = 12-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
  • KAE609 150 mg SD · Fisher Exact · p = 12-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
SecondaryPercentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29

PCR-corrected and PCR-uncorrected were evaluated at Days 15 and 29 (i.e., 14 and 28 days post-dose). The presence of parasitaemia after 7 days due to reinfection was considered as PCR-corrected ACPR. Missing blood smear data at Day 15 visit and thereafter were not considered as responder for the visit unless there was a later blood smear test indicating no parasitaemia.

Time frame:
Day 15, Day 29
Reported as:
Number · Percentage of Participants
Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
Percentage of ParticipantsKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SDPooled Coartem Control
Day 15: PCR corrected90.0 (55.50 to 99.75)90.0 (55.50 to 99.75)83.3 (51.59 to 97.91)95.0 (75.13 to 99.87)95.2 (76.18 to 99.88)84.2 (60.42 to 96.62)90.5 (69.62 to 98.83)77.3 (54.63 to 92.18)96.1 (86.54 to 99.52)
Day 15: PCR uncorrected90.0 (55.50 to 99.75)90.0 (55.50 to 99.75)83.3 (51.59 to 97.91)95.0 (75.13 to 99.87)95.2 (76.18 to 99.88)84.2 (60.42 to 96.62)85.7 (63.66 to 96.95)77.3 (54.63 to 92.18)96.1 (86.54 to 99.52)
Day 29: PCR corrected80.0 (44.39 to 97.48)90.0 (55.50 to 99.75)83.3 (51.59 to 97.91)90.0 (68.30 to 98.77)85.7 (63.66 to 96.95)73.7 (48.80 to 90.85)81.0 (58.09 to 94.55)68.2 (45.13 to 86.14)94.1 (83.76 to 98.77)
Day 29: PCR uncorrected80.0 (44.39 to 97.48)90.0 (55.50 to 99.75)66.7 (34.89 to 90.08)80.0 (56.34 to 94.27)81.0 (58.09 to 94.55)68.4 (43.45 to 87.42)71.4 (47.82 to 88.72)59.1 (36.35 to 79.29)92.2 (81.12 to 97.82)
SecondaryParasite Clearance Time (PCT)

Parasite Clearance Time (PCT) is defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. In case a patient received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication.

Time frame:
Day 29
Reported as:
Mean · Hours
Parasite Clearance Time (PCT)
HoursKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SDPooled Coartem Control
Parasite Clearance Time (PCT)26.8 ± 5.4427.7 ± 4.9614.0 ± 2.6311.4 ± 1.8211.1 ± 1.589.8 ± 0.978.7 ± 0.978.0 ± 1.0936.2 ± 3.72
SecondaryFever Clearance Time (FCT)

Fever Clearance Time (FCT) is defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. In case a patient received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication.

Time frame:
Day 29
Reported as:
Mean · Hours
Fever Clearance Time (FCT)
HoursKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SDPooled Coartem Control
Fever Clearance Time (FCT)3.9 ± NA2.0 ± 0.02NA ± NA22.0 ± 14.032.4 ± 0.937.2 ± 1.475.7 ± 2.029.9 ± 3.8813.0 ± 4.29
SecondaryTime to Recrudescence and Reinfection at Study Day 29

Time to recrudescence is calculated from the date of first study medication to the date of first event. Participants without recrudescence/reinfection after Day 7 are censored at the time of treatment failure or at the time of last parasite assessment if no treatment failure occured.

Time frame:
Day 29
Reported as:
Number · Event probability
Time to Recrudescence and Reinfection at Study Day 29
Event probabilityKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SDPooled Coartem Control
Recrudescence12.5 (1.86 to 61.30)10.0 (1.47 to 52.70)16.7 (4.45 to 51.83)10.0 (2.60 to 34.40)16.0 (5.42 to 41.93)26.3 (11.90 to 52.11)15.9 (5.40 to 41.67)32.5 (16.93 to 56.43)2.4 (0.34 to 15.72)
Reinfection——25.0 (6.91 to 68.52)14.3 (3.78 to 46.06)5.0 (0.72 to 30.53)10.0 (1.47 to 52.70)10.3 (2.67 to 35.25)13.3 (3.51 to 43.61)2.4 (0.34 to 15.72)
SecondaryMaximum Peak Observed Concentration (Cmax)

Maximum Peak Observed Concentration (Cmax)

Time frame:
Day 1, Day 3
Reported as:
Geometric mean · ng/mL
Maximum Peak Observed Concentration (Cmax)
ng/mLKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SD
Day 1179 ± 38.2185 ± 51.2379 ± 42.1503 ± 44.3773 ± 32.4828 ± 35.41270 ± 41.32360 ± 28.5
Day 3—235 ± 37.0—655 ± 27.9—1210 ± 30.7——
SecondaryTmax

Tmax

Time frame:
Day 1, Day 3
Reported as:
Median · Hour
Tmax
HourKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SD
Day 14.00 (1.02 to 12.10)3.92 (1.03 to 6.17)4.01 (2.00 to 8.33)4.25 (2.00 to 23.80)4.12 (1.97 to 10.00)4.12 (2.00 to 6.13)6.01 (3.97 to 12.30)8.07 (1.00 to 24.10)
Day 3—52.7 (50.00 to 60.60)—52.1 (49.90 to 59.60)—52.0 (50.00 to 60.50)——
SecondaryAUC0-24

AUC0-24

Time frame:
Day 1, Day 3
Reported as:
Geometric mean · h*ug/mL
AUC0-24
h*ug/mLKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SD
Day 12.77 ± 48.92.59 ± 38.05.14 ± 52.58.39 ± 45.111.6 ± 37.715.6 ± 27.221.4 ± 41.540.4 ± 26.6
Day 3—3.90 ± 38.5—10.9 ± 29.7—21.6 ± 31.3——
SecondaryHalf-life (T^1/2)

Half-life (T\^1/2)

Time frame:
Upto day 15 post dose
Reported as:
Mean · Hour
Half-life (T^1/2)
HourKAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SD
Day 124.4 ± 8.7018.5 ± 6.2435.1 ± 13.917.4 ± 3.2731.5 ± 17.432.8 ± 5.0525.3 ± 8.9429.9 ± 12.5
Day 3—32.4 ± 14.8—30.1 ± 14.0—29.9 ± 22.0——

Adverse events

Collected over All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
KAE609 10mg SD0/10 (0%)0/10 (0%)9/10 (90%)
KAE609 10mg QD@3 Days0/10 (0%)0/10 (0%)8/10 (80%)
KAE609 25mg SD0/12 (0%)0/12 (0%)10/12 (83.3%)
KAE609 25mg QD@3 Days0/20 (0%)0/20 (0%)10/20 (50%)
KAE609 50mg SD0/21 (0%)0/21 (0%)9/21 (42.9%)
KAE609 50mg QD@3 Days0/19 (0%)1/19 (5.3%)16/19 (84.2%)
KAE609 75mg SD0/21 (0%)2/21 (9.5%)15/21 (71.4%)
KAE609 150mg SD0/22 (0%)1/22 (4.5%)12/22 (54.5%)
Pooled Coartem0/51 (0%)1/51 (2%)25/51 (49%)
Most frequent serious events
Most frequent serious events
EventKAE609 10mg SDKAE609 10mg QD@3 DaysKAE609 25mg SDKAE609 25mg QD@3 DaysKAE609 50mg SDKAE609 50mg QD@3 DaysKAE609 75mg SDKAE609 150mg SDPooled Coartem
Blood bilirubin increasedInvestigations0/100/100/120/200/211/190/210/221/51
ThrombocytopeniaBlood and lymphatic system disorders0/100/100/120/200/210/191/210/220/51
Blood alkaline phosphatase increasedInvestigations0/100/100/120/200/210/191/210/220/51
Alanine aminotransferase increasedInvestigations0/100/100/120/200/210/190/211/220/51
Most frequent other events
Showing 10 of 40
Most frequent other events
EventKAE609 10mg SDKAE609 10mg QD@3 DaysKAE609 25mg SDKAE609 25mg QD@3 DaysKAE609 50mg SDKAE609 50mg QD@3 DaysKAE609 75mg SDKAE609 150mg SDPooled Coartem
HeadacheNervous system disorders3/105/101/121/202/212/195/210/229/51
MalariaInfections and infestations1/100/102/124/204/215/195/219/221/51
Treatment failureGeneral disorders0/101/103/121/200/211/190/210/222/51
InfluenzaInfections and infestations0/100/100/121/200/213/192/213/222/51
CoughRespiratory, thoracic and mediastinal disorders1/100/101/121/201/212/190/210/221/51
LeukopeniaBlood and lymphatic system disorders0/101/100/120/200/210/190/210/220/51
Abdominal painGastrointestinal disorders1/100/100/120/200/210/191/210/221/51
DiarrhoeaGastrointestinal disorders1/100/101/120/200/210/191/210/223/51
DyspepsiaGastrointestinal disorders0/101/100/120/200/210/190/210/220/51
GastritisGastrointestinal disorders1/100/100/120/200/210/190/210/220/51

Baseline characteristics

Randomized set (RAN)

Age, Continuous
Age, Continuous(Years)KAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SDPooled Coartem ControlTotal
Mean31.5 ± 10.4835.4 ± 13.2533.0 ± 14.9631.9 ± 10.6733.9 ± 12.5626.4 ± 7.1828.2 ± 10.2530.6 ± 12.5726.2 ± 9.0729.7 ± 11.07
Sex: Female, Male
Sex: Female, Male(Participants)KAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SDPooled Coartem ControlTotal
Female2681198561873
Male84491312161633115
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)KAE609 10 mg SDKAE609 10 mg QD 3 DaysKAE609 25 mg SDKAE609 25 mg QD 3 DaysKAE609 50 mg SDKAE609 50 mg QD 3 DaysKAE609 75 mg SDKAE609 150 mg SDPooled Coartem ControlTotal
Black or African American101012202220212251188
07

Study locations

9 sites
  • Novartis Investigative Site
    Lambarene, Gabon
  • Novartis Investigative Site
    Kintampo, Ghana
  • Novartis Investigative Site
    Navrango, Ghana
  • Novartis Investigative Site
    Bamako, Mali
  • Novartis Investigative Site
    Sotuba, Mali
  • Novartis Investigative Site
    Kigali, Rwanda
  • Novartis Investigative Site
    Bushenyi, Uganda
  • Novartis Investigative Site
    Kampala, Uganda
  • Novartis Investigative Site
    Tororo, Uganda
08

References and documents

Publications

  • Ndayisaba G, Yeka A, Asante KP, Grobusch MP, Karita E, Mugerwa H, Asiimwe S, Oduro A, Fofana B, Doumbia S, Jain JP, Barsainya S, Kullak-Ublick GA, Su G, Schmitt EK, Csermak K, Gandhi P, Hughes D. Hepatic safety and tolerability of cipargamin (KAE609), in adult patients with Plasmodium falciparum malaria: a randomized, phase II, controlled, dose-escalation trial in sub-Saharan Africa. Malar J. 2021 Dec 20;20(1):478. doi: 10.1186/s12936-021-04009-1. PubMed 34930267 ↗
  • Schmitt EK, Ndayisaba G, Yeka A, Asante KP, Grobusch MP, Karita E, Mugerwa H, Asiimwe S, Oduro A, Fofana B, Doumbia S, Su G, Csermak Renner K, Venishetty VK, Sayyed S, Straimer J, Demin I, Barsainya S, Boulton C, Gandhi P. Efficacy of Cipargamin (KAE609) in a Randomized, Phase II Dose-Escalation Study in Adults in Sub-Saharan Africa With Uncomplicated Plasmodium falciparum Malaria. Clin Infect Dis. 2022 May 30;74(10):1831-1839. doi: 10.1093/cid/ciab716. PubMed 34410358 ↗

Study documents

  • Study protocol · May 27, 2019
  • Statistical analysis plan · Apr 7, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

09

Registry details

Key details

Study ID
NCT03334747
Lead sponsor
Novartis Pharmaceuticals
Collaborators
Wellcome Trust
Responsible party
Sponsor
First posted
Nov 7, 2017
Start date
Nov 16, 2017
Primary completion
Nov 23, 2019
Completion
Nov 23, 2019
Results posted
Sep 25, 2020
Last update
Oct 11, 2021

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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