Trial Outcomes & Findings for Efficacy, Safety, and PK of Ascending Dosages of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis (NCT NCT04056325)
NCT ID: NCT04056325
Last Updated: 2024-12-09
Results Overview
The conversion from being larvae positive pre-treatment to larvae negative post-treatment, or cure rate (CR).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
617 participants
Primary outcome timeframe
Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatment
Results posted on
2024-12-09
Participant Flow
Participant milestones
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
8 mg moxidectin (i.e. the most promising dosage identified in trial A; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2a
STARTED
|
31
|
33
|
33
|
32
|
32
|
30
|
32
|
0
|
0
|
|
Phase 2a
COMPLETED
|
30
|
29
|
32
|
29
|
30
|
30
|
29
|
0
|
0
|
|
Phase 2a
NOT COMPLETED
|
1
|
4
|
1
|
3
|
2
|
0
|
3
|
0
|
0
|
|
Phase 2b
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
197
|
197
|
|
Phase 2b
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
192
|
189
|
|
Phase 2b
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
Baseline characteristics by cohort
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
n=31 Participants
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
n=33 Participants
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
n=33 Participants
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=32 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
n=32 Participants
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
n=30 Participants
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
n=32 Participants
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
n=197 Participants
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
n=197 Participants
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
Total
n=617 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 10.7 • n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
46.3 years
STANDARD_DEVIATION 12.5 • n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
45.3 years
STANDARD_DEVIATION 11.8 • n=32 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
44.0 years
STANDARD_DEVIATION 13.5 • n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
44.4 years
STANDARD_DEVIATION 11.8 • n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
44.3 years
STANDARD_DEVIATION 11.2 • n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
40.0 years
STANDARD_DEVIATION 10.7 • n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
45.4 years
STANDARD_DEVIATION 11.6 • n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
44.8 years
STANDARD_DEVIATION 11.1 • n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
45.1 years
STANDARD_DEVIATION 11.3 • n=603 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
|
Sex: Female, Male
Female
|
12 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
8 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
10 Participants
n=32 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
9 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
13 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
9 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
10 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
89 Participants
n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
94 Participants
n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
254 Participants
n=603 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
|
Sex: Female, Male
Male
|
18 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
21 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
22 Participants
n=32 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
20 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
17 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
21 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
19 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
108 Participants
n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
103 Participants
n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
349 Participants
n=603 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Laos
|
31 participants
n=31 Participants
|
33 participants
n=33 Participants
|
33 participants
n=33 Participants
|
32 participants
n=32 Participants
|
32 participants
n=32 Participants
|
30 participants
n=30 Participants
|
32 participants
n=32 Participants
|
197 participants
n=197 Participants
|
197 participants
n=197 Participants
|
617 participants
n=617 Participants
|
|
Strongyloides stercoralis infection intensity
Light
|
6 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
4 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
6 Participants
n=32 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
3 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
5 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
3 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
4 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
47 Participants
n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
53 Participants
n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
131 Participants
n=603 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
|
Strongyloides stercoralis infection intensity
Moderate
|
13 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
13 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
14 Participants
n=32 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
12 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
12 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
13 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
12 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
85 Participants
n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
83 Participants
n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
257 Participants
n=603 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
|
Strongyloides stercoralis infection intensity
Heavy
|
11 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
12 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
12 Participants
n=32 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
14 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
13 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
14 Participants
n=30 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
13 Participants
n=29 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
65 Participants
n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
61 Participants
n=197 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
215 Participants
n=603 Participants • In phase 2a, the analysis population is the intention-to-treat population, excluding participants lost to follow-up. In phase 2b, the analysis population includes all randomized participants.
|
PRIMARY outcome
Timeframe: Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatmentThe conversion from being larvae positive pre-treatment to larvae negative post-treatment, or cure rate (CR).
Outcome measures
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
n=30 Participants
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
n=29 Participants
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
n=32 Participants
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=29 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
n=30 Participants
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
n=30 Participants
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
n=29 Participants
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
n=192 Participants
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
n=189 Participants
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Observed Cure Rate Against Strongyloides Stercoralis
|
73.3 percentage of participants
Interval 54.1 to 87.7
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
84.4 percentage of participants
Interval 67.2 to 94.7
|
82.8 percentage of participants
Interval 64.2 to 94.2
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
87.1 percentage of participants
Interval 70.2 to 96.4
|
13.8 percentage of participants
Interval 3.9 to 31.7
|
92.7 percentage of participants
Interval 88.1 to 96.0
|
92.6 percentage of participants
Interval 87.9 to 95.9
|
SECONDARY outcome
Timeframe: Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatmentLarvae per gram (LPG) stool sample will be assessed by calculating the mean of the larvae counts from the three duplicate Baermann assays and divided by the mean weighted amount of these stool samples. The LRR will be calculated following: (LRR = (1-(mean at follow-up/mean at baseline))\*100)
Outcome measures
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
n=30 Participants
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
n=29 Participants
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
n=32 Participants
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=29 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
n=30 Participants
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
n=30 Participants
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
n=29 Participants
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
n=192 Participants
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
n=189 Participants
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Observed Larvae-reduction Rate (LRR) Against Strongyloides Stercoralis
|
98.4 percent change
Interval 93.7 to 99.9
|
99.4 percent change
Interval 98.1 to 100.0
|
99.8 percent change
Interval 99.3 to 100.0
|
97.8 percent change
Interval 93.2 to 99.9
|
98.6 percent change
Interval 95.1 to 100.0
|
98.5 percent change
Interval 95.6 to 99.9
|
27.0 percent change
Interval -2.2 to 48.3
|
99.6 percent change
Interval 99.1 to 100.0
|
99.9 percent change
Interval 99.8 to 100.0
|
SECONDARY outcome
Timeframe: Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatmentPopulation: Participants co-infected with A. lumbricoides
CRs will be calculated for Ascaris lumbricoides infections as described in primary outcome.
Outcome measures
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
n=1 Participants
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
n=1 Participants
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=1 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
n=1 Participants
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
n=1 Participants
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
n=9 Participants
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
n=6 Participants
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Observed CRs Against Concomitant Soil-transmitted Helminth Infections - Ascaris Lumbricoides
|
—
|
0 percentage of participants
Interval 0.0 to 0.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
100 percentage of participants
Interval 100.0 to 100.0
|
83.3 percentage of participants
Interval 40.5 to 100.0
|
SECONDARY outcome
Timeframe: Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatmentPopulation: Number of Participants co-infected with T. trichiura
CRs will be calculated for Trichuris trichiura infections as described in primary outcome.
Outcome measures
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
n=2 Participants
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
n=2 Participants
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
n=2 Participants
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=3 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
n=1 Participants
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
n=1 Participants
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
n=2 Participants
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
n=10 Participants
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
n=17 Participants
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Observed CRs Against Concomitant Soil-transmitted Helminth Infections - Trichuris Trichiura
|
100 percentage of participants
|
100 percentage of participants
|
50 percentage of participants
|
33 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatmentPopulation: Participants co-infected with Hookworm
CRs will be calculated for Hookworm infections as described in primary outcome.
Outcome measures
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
n=17 Participants
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
n=18 Participants
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
n=21 Participants
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=17 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
n=20 Participants
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
n=21 Participants
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
n=17 Participants
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
n=94 Participants
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
n=97 Participants
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Observed CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm
|
0 percentage of participants
|
11 percentage of participants
|
14 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
29 percentage of participants
|
0 percentage of participants
|
31.9 percentage of participants
|
17.5 percentage of participants
|
SECONDARY outcome
Timeframe: 2-3 hours, 24 hours, and retrospectively 21-28 days (phase 2a) or 14-21 days (phase 2b Arm A and Arm B) after treatment.Population: Phase 2a: Analysis population N=209 at all time points. Phase 2b: Analysis population at 2-3 hours after drug administration: N=394. Analysis population at 24 hours after drug administration: N=394. Analysis population at 14-21 days after drug administration: N=381.
Subjects will be kept for observation for at least 3 hours following treatment for any acute AEs. If there is any abnormal finding, the local study physician will perform a full clinical, physical and biochemical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. In addition patients will also be interviewed 2-3 and 24 hours and again 3-4 (phase 2a) or 2-3 (phase 2b) weeks after treatment about the occurrence of AEs. A standardized symptom questionnaire is used, that includes the recording of headache, abdominal pain, itching, nausea, vomiting, diarrhea, allergic reaction as well as any further mentioned event by the participant.
Outcome measures
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
n=30 Participants
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
n=29 Participants
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
n=32 Participants
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=29 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
n=30 Participants
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
n=30 Participants
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
n=29 Participants
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
n=197 Participants
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
n=197 Participants
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events
24 hours: Diarrhea
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Allergic reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
21-28/14-21 days: Diarrhea
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Headache
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
11 Participants
|
9 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Abdominal pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Itching
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Diarrhea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
2-3 hours: Allergic reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
12 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Abdominal pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
21 Participants
|
21 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Itching
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
24 hours: Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants Reporting Adverse Events
21-28/14-21 days: Headache
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events
21-28/14-21 days: Abdominal pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
12 Participants
|
5 Participants
|
|
Number of Participants Reporting Adverse Events
21-28/14-21 days: Itching
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events
21-28/14-21 days: Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events
21-28/14-21 days: Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events
21-28/14-21 days: Allergic reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 0, 2, 4, 6, 7, 24, and 72 hours, and 28 days after treatment.Population: Data were only collected in phase 2a - Arm D (Moxidectin 8 mg).
Upon oral intake moxidectin levels in blood will be quantified with time using a micro sampling device. Moxidectin will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 5 ng/ml. The PK analysis will be undertaken fitting a structural compartmental PK model.
Outcome measures
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=9 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Moxidectin in Adults
|
—
|
—
|
—
|
86.1 ng/mL
Interval 76.7 to 89.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 2, 4, 6, 7, 24, and 72 hours, and 28 days after treatment.Population: Data were only collected in phase 2a - Arm D (Moxidectin 8 mg).
Upon oral intake moxidectin levels in blood will be quantified with time using a micro sampling device. Moxidectin will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 5 ng/ml. The PK analysis will be undertaken fitting a structural compartmental PK model.
Outcome measures
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=9 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of Moxidectin in Adults
|
—
|
—
|
—
|
4 hours
Interval 4.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 2, 4, 6, 7, 24, and 72 hours, and 28 days after treatment.Population: Data were only collected in phase 2a - Arm D (Moxidectin 8 mg).
Upon oral intake moxidectin levels in blood will be quantified with time using a micro sampling device. Moxidectin will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 5 ng/ml. The PK analysis will be undertaken fitting a structural compartmental PK model.
Outcome measures
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=9 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC) of Moxidectin in Adults
|
—
|
—
|
—
|
5028 ng/mL*h
Interval 4286.0 to 5578.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 2, 4, 6, 7, 24, and 72 hours, and 28 days after treatment.Population: Data were only collected in phase 2a - Arm D (Moxidectin 8 mg).
Upon oral intake moxidectin levels in blood will be quantified with time using a micro sampling device. Moxidectin will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 5 ng/ml. The PK analysis will be undertaken fitting a structural compartmental PK model.
Outcome measures
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=9 Participants
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Elimination Half Life (T1/2) of Moxidectin in Adults
|
—
|
—
|
—
|
666 hours
Interval 562.0 to 759.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 2a - Arm A (Moxidectin 2 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2a - Arm B (Moxidectin 4 mg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2a - Arm C (Moxidectin 6 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2a - Arm D (Moxidectin 8 mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 2a - Arm E (Moxidectin 10 mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2a - Arm F (Moxidectin 12 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2a - Arm G (Placebo)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase 2b - Arm A (Moxidectin)
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Phase 2b - Arm B (Ivermectin)
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 2a - Arm A (Moxidectin 2 mg)
n=31 participants at risk
2 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm B (Moxidectin 4 mg)
n=33 participants at risk
4 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm C (Moxidectin 6 mg)
n=33 participants at risk
6 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm D (Moxidectin 8 mg)
n=32 participants at risk
8 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm E (Moxidectin 10 mg)
n=32 participants at risk
10 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm F (Moxidectin 12 mg)
n=30 participants at risk
12 mg Moxidectin at day 0 administered orally
|
Phase 2a - Arm G (Placebo)
n=32 participants at risk
matching Placebo tablet(s) at day 0 administered orally
|
Phase 2b - Arm A (Moxidectin)
n=197 participants at risk
8 mg moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally
\+ Ivermectin placebo dose, corresponding to Phase 2b - Arm B
|
Phase 2b - Arm B (Ivermectin)
n=197 participants at risk
200 µg/kg ivermectin at day 0 administered orally
\+ Moxidectin placebo dose, corresponding to Phase 2b - Arm A
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/31 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/33 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/33 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/32 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
6.2%
2/32 • Number of events 2 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/30 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.1%
1/32 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
20.8%
41/197 • Number of events 45 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
17.3%
34/197 • Number of events 36 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
6.1%
2/33 • Number of events 2 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/33 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.1%
1/32 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.1%
1/32 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/30 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.1%
1/32 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
1.0%
2/197 • Number of events 2 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
2.5%
5/197 • Number of events 5 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/33 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/33 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/32 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/32 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/30 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.1%
1/32 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.6%
7/197 • Number of events 7 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.0%
6/197 • Number of events 6 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
|
General disorders
Headache
|
9.7%
3/31 • Number of events 3 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
6.1%
2/33 • Number of events 2 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
6.1%
2/33 • Number of events 2 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
9.4%
3/32 • Number of events 3 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
12.5%
4/32 • Number of events 4 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.3%
1/30 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
25.0%
8/32 • Number of events 8 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
12.7%
25/197 • Number of events 26 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
10.7%
21/197 • Number of events 22 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
|
General disorders
Nausea
|
0.00%
0/31 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/33 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/33 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/32 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/32 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/30 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.1%
1/32 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.0%
6/197 • Number of events 8 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
1.0%
2/197 • Number of events 2 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
|
General disorders
Allergic reaction
|
0.00%
0/31 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/33 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/33 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.1%
1/32 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/32 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/30 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/32 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/197 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
1.5%
3/197 • Number of events 3 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/31 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
6.1%
2/33 • Number of events 2 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.0%
1/33 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/32 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/32 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
0.00%
0/30 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
3.1%
1/32 • Number of events 1 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
7.6%
15/197 • Number of events 16 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
4.1%
8/197 • Number of events 8 • 21-28 days (phase 2a) / 14-21 days (phase 2b)
Participants were monitored at the site for 3 hours following treatment. In addition, participants were interviewed at 2-3 and 24 hours after treatment and retrospectively at 21-28 days (phase 2a) or 14-21 days (phase 2b) about the occurrence of adverse events.
|
Additional Information
Prof Dr Jennifer Keiser
Swiss Tropical and Public Health Institute
Phone: +41 61 284 82 18
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place