Trial · NCT03167242
Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
NCT03167242, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2022-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria. Trials, record NCT03167242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03167242
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
- NCT number
- NCT03167242
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 524 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acute Uncomplicated Plasmodium Falciparum Malaria
- Interventions
- KAF156, Coartem, Lumefantrine Solid Dispersion Formulation
- First posted
- 2017-05-25
- Last updated
- 2022-02-10
- Other registries' IDs
- eudract:2020-003284-25
- Results first posted
- 2022-02-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | 28 days post first dose | PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at Day 29 (i.e., 28 days post first dose) based on the short half-life of the study drugs. Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR at Day 29 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 29 irrespective of axillary temperature unless the presence of parasitaemia after 7 days was due to reinfection based on PCR. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. |
| Primary | PK Run-in: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Treatment Dose (AUC0-24h) of KAF156 | 0, 1, 3, 6, 12, 18 and 24 hours post-dose | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods. |
| Secondary | Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Uncorrected Adequate Clinical and Parasitological Response (ACPR) | 14, 28 and 42 days post first dose | PCR-uncorrected ACPR defined as the absence of parasitaemia was evaluated at days 15, 29 and 43 (i.e., 14, 28 and 42 days post first dose). A participant was considered as PCR-uncorrected ACPR at Days 15, 29 or 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Days 15, 29 or 43 irrespective of axillary temperature. |
| Secondary | Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) | 14 and 42 days post first dose | PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at days 15 and 43 (i.e., 14 and 42 days post first dose). Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR at Day 15 or Day 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 15 or Day 43 irrespective of axillary temperature unless the presence of parasitaemia after 7 days was due to reinfection based on PCR. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. |
| Secondary | Part A and Part B: Number of Participants With Recrudescence Events | 42 days post first dose | Recrudescence is defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Recrudescence must be confirmed by PCR analysis. |
| Secondary | Part A and Part B: Number of Participants With Reinfection Events | 42 days post first dose | Reinfection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. Reinfection must be confirmed by PCR analysis. |
| Secondary | Part A and Part B: Fever Clearance Time (FCT) | 42 days post first dose | 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 participant received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication. |
| Secondary | PK Run-in, Part A and Part B: Parasite Clearance Time (PCT) | 42 days post first dose | 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 participant received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication. |
| Secondary | PK Run-in, Part A and Part B: Number of Participants With Parasitaemia | 12, 24 and 48 hours post last dose | Parasitaemia is the quantitative content of parasites in the blood determined by microscopy examination validated methods. Only Plasmodium Falciparum asexual form is used for parasitaemia assessments. |
| Secondary | Part A and Part B: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Last Treatment Dose (AUC0-24h) of KAF156 | 3, 6, 18 and 24 hours post last dose | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | 28 days post first dose | All participants comprised in Per-protocol Set (PPS) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | PK Run-in: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Treatment Dose (AUC0-24h) of KAF156 | 0, 1, 3, 6, 12, 18 and 24 hours post-dose | Pharmacokinetics (PK) Analysis Set. Only participants with available PK data at the specified time point were included in the analysis. | hours*μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Uncorrected Adequate Clinical and Parasitological Response (ACPR) | 14, 28 and 42 days post first dose | All participants comprised in Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) | 14 and 42 days post first dose | All participants comprised in Per-protocol Set (PPS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A and Part B: Number of Participants With Recrudescence Events | 42 days post first dose | All participants comprised in Full Analysis Set (FAS). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A and Part B: Number of Participants With Reinfection Events | 42 days post first dose | All participants comprised in Full Analysis Set (FAS). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A and Part B: Fever Clearance Time (FCT) | 42 days post first dose | Full Analysis Set (FAS). Only participants with fever at baseline and post-baseline assessment of fever clearance at the time point were included in the analysis. | Hours | MEAN |
| SECONDARY | PK Run-in, Part A and Part B: Parasite Clearance Time (PCT) | 42 days post first dose | All participants comprised in Full Analysis Set (FAS). | Hours | MEAN |
| SECONDARY | PK Run-in, Part A and Part B: Number of Participants With Parasitaemia | 12, 24 and 48 hours post last dose | Full Analysis Set (FAS). Only participants with assessment of parasitaemia at the timepoint were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A and Part B: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Last Treatment Dose (AUC0-24h) of KAF156 | 3, 6, 18 and 24 hours post last dose | Pharmacokinetics (PK) Analysis Set. Only participants with available PK data at the specified time point were included in the analysis. As per study design, AUC0-24h was not determined for Part B cohorts 2 and 3. | hours*μg/mL | GEOMETRIC_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group174
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | 46 | Participants | ||
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day | 45 | Participants | ||
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days | 47 | Participants | ||
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days | 47 | Participants | ||
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | 44 | Participants | ||
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | 42 | Participants | ||
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | Part A - Cohort 7: Coartem | 25 | Participants | ||
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | 37 | Participants | ||
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | 42 | Participants | ||
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | 38 | Participants |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day | 12 | |
| Overall Study | STARTED | Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | 51 | |
| Overall Study | STARTED | Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day | 51 | |
| Overall Study | STARTED | Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days | 51 | |
| Overall Study | STARTED | Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days | 54 | |
| Overall Study | STARTED | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | 51 | |
| Overall Study | STARTED | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | 52 | |
| Overall Study | STARTED | Part A - Cohort 7: Coartem | 27 | |
| Overall Study | STARTED | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | 53 | |
| Overall Study | STARTED | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | 53 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events240
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PK Run-in: KAF 200 mg and LUM 960 mg QD for 1 Day | 0 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: KAF 800 mg and LUM 960 mg QD for 1 Day | 0 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: KAF 200 mg and LUM 480 mg QD for 3 Days | 1 | 54 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: KAF 400 mg and LUM 480 mg QD for 3 Days | 1 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A and Part B: KAF 400 mg and LUM 960 mg QD for 1 Day | 5 | 103 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A and Part B: KAF 400 mg and LUM 960 mg QD for 2 Days | 3 | 104 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A and Part B: KAF 400 mg and LUM 960 mg QD for 3 Days | 5 | 97 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A and Part B: Coartem | 1 | 51 | |
| other | Eosinophilia | Blood and lymphatic system disorders | PK Run-in: KAF 200 mg and LUM 960 mg QD for 1 Day | 0 | 12 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Part A: KAF 800 mg and LUM 960 mg QD for 1 Day | 2 | 51 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PK Run-in: KAF 200 mg and LUM 960 mg QD for 1 Day | 0 | 12 |
| Total, all-cause mortality | Part A: KAF 800 mg and LUM 960 mg QD for 1 Day | 0 | 51 |
| Total, all-cause mortality | Part A: KAF 200 mg and LUM 480 mg QD for 3 Days | 0 | 54 |
| Total, all-cause mortality | Part A: KAF 400 mg and LUM 480 mg QD for 3 Days | 0 | 51 |
| Total, all-cause mortality | Part A and Part B: KAF 400 mg and LUM 960 mg QD for 1 Day | 0 | 103 |
| Total, all-cause mortality | Part A and Part B: KAF 400 mg and LUM 960 mg QD for 2 Days | 0 | 104 |
| Total, all-cause mortality | Part A and Part B: KAF 400 mg and LUM 960 mg QD for 3 Days | 0 | 97 |
| Total, all-cause mortality | Part A and Part B: Coartem | 0 | 51 |
| Total, other adverse events | PK Run-in: KAF 200 mg and LUM 960 mg QD for 1 Day | 7 | 12 |
| Total, other adverse events | Part A: KAF 800 mg and LUM 960 mg QD for 1 Day | 37 | 51 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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