Trial · NCT03167242
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| SECONDARY | Part A and Part B: Maximum Peak Observed Concentration (Cmax) of KAF156 | 3, 6, 18, 24, 27, 30, 48, 51, 54, 68, 72 and 168 hours post last dose | Pharmacokinetics (PK) Analysis Set. Only participants with available PK data at the specified time point were included in the analysis. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | PK Run-in and Part A: Elimination Half-life (T½) of KAF156 | 0, 1, 3, 6, 12, 18, 24, 27, 30, 36, 48, 72, 96 and 168 hours post last dose | Rich Pharmacokinetics (PK) Analysis subset. Only participants with available PK data at the specified time point were included in the analysis. | Hours | MEAN |
| SECONDARY | PK Run-in and Part A (Cohorts 1 and 2): Time to Reach Maximum Blood Concentrations (Tmax) of KAF156 | 0, 1, 3, 6, 12, 18, 24, 30, 48, 96 and 168 hours post last dose | Rich Pharmacokinetics (PK) Analysis subset. Only participants with available PK data at the specified time point were included in the analysis. As per study design, Tmax was only determined per PK Run-in and Part A cohorts 1 and 2. | Hours | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03167242/outcomes