Trial · NCT03660839
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28) | Day 28 | Pharmacokinetic/Pharmacodynamic (PK/PD) efficacy population: who received at least 1 dose of OZ439/FQ with parasitologically confirmed Plasmodium falciparum at baseline with data post-randomization, 1 evaluable PK blood sample (OZ439/FQ) post dose, adequate documentation of dosing \& sampling date, without any major protocol deviation related to drug administration (e.g. vomiting after drug intake). Here,overall number of participants analyzed=participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28 | Day 28 | Analysis was performed on PK/PD efficacy population. | percentage of participants | NUMBER |
| SECONDARY | Parasitemia: Change From Baseline in Number of Parasites Per Microliter of Blood at 6, 12, 18, 24, 30, 36, 48, 72, 96, 120, 144 and 168 Hours | Baseline, 6, 12, 18, 24, 30, 36, 48, 72, 96, 120, 144 and 168 hours post-dose | Analysis was performed on modified intention-to-treat (mITT) population which included all randomized participants with parasitological confirmed P.falciparum malaria at baseline with parasitemia data post-randomization, received the single administration of OZ439/FQ. Here, number analyzed = participants with available data for each specified category. | parasites per microliter | MEAN |
| SECONDARY | Observed Parasite Reduction Ratio (PRR) at 24 Hours, 48 Hours, and 72 Hours | Baseline, 24, 48 and 72 hours post-dose | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. | ratio | MEAN |
| SECONDARY | Time to 50% and 99% Parasite Reduction | Up to Day 28 | Analysis was performed on mITT population. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | hours | MEAN |
| SECONDARY | Parasite Clearance Time (PCT) | From the start of study drug administration up to the time of the first negative blood film (up to Day 28) | Analysis was performed on mITT population. | hours | MEDIAN |
| SECONDARY | Parasite Clearance Rate | Up to Day 28 | Analysis was performed on mITT population. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | 1 per hour | MEAN |
| SECONDARY | Time to Re-emergence | Up to Day 28 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | Time to Recrudescence | Up to Day 28 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | Time to Re-infection | Up to Day 28 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | Time Elapsed Below the Limit of Quantification (LOQ) of Parasitemia | Up to Day 28 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI) | From Baseline up to Day 28 | Analysis was performed on safety population: participants who received single administration of OZ439/FQ and were analyzed according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK): Concentration of OZ439 in Plasma | 1, 2, 4, 6, 12, 24, 48, 72, 120, 168 and 336 hours post-dose | Analysis was performed on PK population which included all participants who received OZ439 and had at least one evaluable blood sample for PK OZ439 post study drug administration and with adequate documentation of date of dosing and date of sampling. Here, 'number analyzed' = participants with available data for each specified category. | nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Concentration of FQ and Its Active Metabolite SSR97213 in Blood | 1, 4, 6, 8, 12, 24, 72, 168, 336 and 672 hours post-dose | Analysis was performed on PK population which included all participants who received FQ and had at least one evaluable blood sample for PK FQ post study drug administration and with adequate documentation of date of dosing and date of sampling. Here, 'number analyzed' = participants with available data for each specified category. | nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Artefenomel | Pre-dose, 1, 2, 4, 6, 12, 24, 48, 72, 120, 168 and 336 hours post-dose | Analysis was performed on PK/PD efficacy population. | nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Time to Reach Maximum Plasma Concentration (Tmax) of Artefenomel | Pre-dose, 1, 2, 4, 6, 12, 24, 48, 72, 120, 168 and 336 hours post-dose | Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since tmax was not considered relevant to the objective of exposure-response analysis, data for this outcome measure were not collected and reported. | ||
| SECONDARY | Pharmacokinetics: Plasma Concentration at 168 Hours Post-dose (C168h) of Artefenomel | At 168 hours post-dose | Analysis was performed on PK/PD efficacy population. | nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Area Under the Concentration Curve (AUC) Form Time 0 to Infinity (AUC0-inf]) of Artefenomel | Pre-dose, 1, 2, 4, 6, 12, 24, 48, 72, 120, 168 and 336 hours post-dose | Analysis was performed on PK/PD efficacy population. | micrograms*hour per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Terminal Half-life (t1/2) of Artefenomel | Pre-dose, 1, 2, 4, 6, 12, 24, 48, 72, 120, 168 and 336 hours post-dose | Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since terminal t1/2 was not considered relevant to the objective of exposure-response analysis, therefore data for this outcome measure were not collected and reported. | ||
| SECONDARY | Pharmacokinetics: Maximum Observed Plasma Concentration of Ferroquine and Its Active Metabolite SSR97213 | Pre-dose, 1, 4, 6, 8, 12, 24, 72, 168, 336 and 672 hours post-dose | Analysis was performed on PK/PD efficacy population. | nanograms per milliliter | GEOMETRIC_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.
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