Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Exploratory outcome: occurrence of dermatitis and/or pruritus |
|
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Other |
Exploratory outcome: occurrence of positive results on blood and skin samples analyzed by Immuno-Histochemistry (IHC), TBR- PCR and/or 18S-PCR |
|
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Other |
Exploratory outcome: occurrence of positive results on blood and skin samples analyzed by qPCRs, multiplex qRT-PCRs and SHERLOCK (Specific High-sensitivity Enzymatic Reporter unlocking) |
|
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Other |
Exploratory outcome: descriptive comparisons between groups and timepoints in occurrence of dermatitis, pruritus, positive results in skin and blood samples analyzed by IHC, qPCRs, multiplex qRT-PCRs and SHERLOCK |
|
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Other |
Exploratory outcome: occurrence comparisons between all diagnostic methods alone or in combination |
|
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Primary |
Occurrence of treatment-emergent adverse events (TEAEs) |
Occurrence of any Treatment Emergent Adverse Event from investigational product administration to 4 month follow-up visit |
From Investigational Product administration to 4 months follow up visit (End of Study) |
|
Secondary |
Occurrence of adverse events (AEs) |
Occurrence of any Adverse Event from Inform Consent signature to 4 month follow-up visit |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Alanine Aminotransferase |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Albumin |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Alkaline Phosphatase |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Aspartate Aminotransferase |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Calcium |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Chloride |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Creatinine |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Glucose |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Potassium |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Sodium |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Total Bilirubin |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Total Carbon Dioxide |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Total Protein |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in biochemistry parameter: Blood Urea Nitrogen |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in hematology parameter: hemoglobin |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in hematology parameter: Platelets |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in hematology parameter: white blood cells |
Changes from baseline at D5, M1 and M4 will be will be presented by treatment group and summarized using mean, standard deviation, median, interquartile range (Q1-Q2) and range (minimum - maximum). Changes from baseline will also be presented as shift table expressed by % of subjects with low, normal or high value for each parameter and each timepoint. |
From Inform Consent signature to 4 months follow up visit (End of Study) |
|
Secondary |
Change from baseline in ECG (Electrocardiogram) parameter: heart rate (HR) |
change from baseline (?) at D5 will be summarized by treatment group and Placebo -corrected change from baseline (??) will be calculated using an analysis of covariance model adjusting for sex and age. |
From Inform Consent signature to Day 5 (end of Hospitalization) |
|
Secondary |
Change from baseline in ECG (Electrocardiogram) parameter: RR interval |
change from baseline (?) at D5 will be summarized by treatment group and Placebo -corrected change from baseline (??) will be calculated using an analysis of covariance model adjusting for sex and age. |
From Inform Consent signature to Day 5 (end of Hospitalization) |
|
Secondary |
Change from baseline in ECG (Electrocardiogram) parameter: PR interval |
change from baseline (?) at D5 will be summarized by treatment group and Placebo -corrected change from baseline (??) will be calculated using an analysis of covariance model adjusting for sex and age. |
From Inform Consent signature to Day 5 (end of Hospitalization) |
|
Secondary |
Change from baseline in ECG (Electrocardiogram) parameter: QRS interval |
change from baseline (?) at D5 will be summarized by treatment group and Placebo -corrected change from baseline (??) will be calculated using an analysis of covariance model adjusting for sex and age. |
From Inform Consent signature to Day 5 (end of Hospitalization) |
|
Secondary |
Change from baseline in ECG (Electrocardiogram) parameter: QT interval |
change from baseline (?) at D5 will be summarized by treatment group and Placebo -corrected change from baseline (??) will be calculated using an analysis of covariance model adjusting for sex and age. |
From Inform Consent signature to Day 5 (end of Hospitalization) |
|
Secondary |
Change from baseline in ECG (Electrocardiogram) parameter: QTc interval |
change from baseline (?) at D5 will be summarized by treatment group and Placebo -corrected change from baseline (??) will be calculated using an analysis of covariance model adjusting for sex and age. |
From Inform Consent signature to Day 5 (end of Hospitalization) |
|
Secondary |
Blood concentration of acoziborole at Day 5 and Month 1 |
Concentration of acoziborole in whole blood at Day 5 and Month 1 |
Day 5 and 1 month follow-up visit |
|
Secondary |
Correlation between ?QTc measurements and acoziborole concentrations in blood at Day 5 |
|
Day 5 |
|