A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether-Lumefantrine in Benin Subjects
Table 2
Variation in haematologic parameters of patients in both treatment arms.
Parameters
Treatment arms
D1 (baseline)
D2
D3
D4
D7
D14
D21
D28
Hb (rate) (×101)
CoBaT-Y017
13.7 ± 1.9
13.5 ± 1.8
13.3 ± 2.1
13.3 ± 1.8
13.2 ± 1.9
12.9 ± 1.5
13.2 ± 1.7
13.4 ± 1.6
AL
13.5 ± 1.7
13.5 ± 2.1
12.92 ± 1.9
12.54 ± 1.2
12.66 ± 1.5
13.25 ± 1.1
13.58 ± 1.1
16.0±6.7
RC (×109)
CoBaT-Y017
5.23 ± 1.4
4.69 ± 0.6
4.76 ± 0.8
4.84 ± 0.7
4.61 ± 0.8
4.53 ± 0.8
4.69 ± 0.8
4.61 ± 0.7
AL
5 ± 0.6
4.75 ± 0.9
4.33 ± 0.8
4.63 ± 0.7
4.75 ± 0.8
4.83 ± 0.7
5 ± 0.6
5.16 ± 0.8
WC (×103)
CoBaT-Y017
5.4 ± 2.1
5.4 ± 2.8
9.3±4.8
4.8 ± 1.3
6.6 ± 2.8
9.5±4.1
9.15±4.1
4.2 ± 1.9
AL
4.6 ± 1.2
4.9 ± 1.6
4.5±2.02
5.1 ± 1.9
5.4 ± 1.5
5.5±1.5
4.5±1.1
4.3 ± 1.7
Plat. (×103)
CoBaT-Y017
0.2 ± 0.06
0.17 ± 0.09
0.2 ± 0.08
0.2 ± 0.08
0.2 ± 0.08
0.3 ± 0.2
0.3 ± 0.08
0.2 ± 0.08
AL
0.2 ± 0.1
0.2 ± 0.09
0.2 ± 0.09
0.2 ± 0.12
0.3 ± 0.2
0.4 ± 0.1
0.3 ± 0.06
0.2 ± 0.04
RC: red blood cells; WC: white cells; Plat: platelets; Hb: haemoglobin. Comparative effects of CoBaT-Y017 and AL on hepatic parameters.