Trial Outcomes & Findings for Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent (NCT NCT02888106)
NCT ID: NCT02888106
Last Updated: 2021-04-30
Results Overview
Negativation of HDV RNA by PCR (undetectable HDV RNA) at Week 72 (end of follow-up period)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
72 weeks
Results posted on
2021-04-30
Participant Flow
Participant milestones
| Measure |
Arm A
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
Myrcludex B 2 mg for 48 weeks
|
Arm E
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
10
|
13
|
15
|
13
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm A
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
Myrcludex B 2 mg for 48 weeks
|
Arm E
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal of consent
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
Baseline characteristics by cohort
| Measure |
Arm A
n=15 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=15 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=15 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=15 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
90 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
36.2 years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
34.3 years
STANDARD_DEVIATION 7.2 • n=8 Participants
|
36.8 years
STANDARD_DEVIATION 7.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
57 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
88 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Russia
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
15 participants
n=21 Participants
|
15 participants
n=8 Participants
|
90 participants
n=8 Participants
|
|
Height
|
168.9 cm
STANDARD_DEVIATION 6.8 • n=5 Participants
|
172.5 cm
STANDARD_DEVIATION 9.4 • n=7 Participants
|
171.4 cm
STANDARD_DEVIATION 6.0 • n=5 Participants
|
174.6 cm
STANDARD_DEVIATION 8.6 • n=4 Participants
|
174.1 cm
STANDARD_DEVIATION 8.2 • n=21 Participants
|
173.5 cm
STANDARD_DEVIATION 6.8 • n=8 Participants
|
172.5 cm
STANDARD_DEVIATION 7.7 • n=8 Participants
|
|
Body Weight
|
68.02 kg
STANDARD_DEVIATION 14.61 • n=5 Participants
|
74.29 kg
STANDARD_DEVIATION 14.44 • n=7 Participants
|
72.37 kg
STANDARD_DEVIATION 11.55 • n=5 Participants
|
82.95 kg
STANDARD_DEVIATION 16.38 • n=4 Participants
|
72.67 kg
STANDARD_DEVIATION 10.01 • n=21 Participants
|
70.53 kg
STANDARD_DEVIATION 9.08 • n=8 Participants
|
73.47 kg
STANDARD_DEVIATION 13.43 • n=8 Participants
|
|
Body Mass Idex
|
23.77 kg/m²
STANDARD_DEVIATION 4.68 • n=5 Participants
|
24.83 kg/m²
STANDARD_DEVIATION 3.46 • n=7 Participants
|
24.69 kg/m²
STANDARD_DEVIATION 4.18 • n=5 Participants
|
27.02 kg/m²
STANDARD_DEVIATION 3.91 • n=4 Participants
|
24.03 kg/m²
STANDARD_DEVIATION 3.21 • n=21 Participants
|
23.48 kg/m²
STANDARD_DEVIATION 3.31 • n=8 Participants
|
24.64 kg/m²
STANDARD_DEVIATION 3.90 • n=8 Participants
|
PRIMARY outcome
Timeframe: 72 weeksPopulation: FAS
Negativation of HDV RNA by PCR (undetectable HDV RNA) at Week 72 (end of follow-up period)
Outcome measures
| Measure |
Arm A
n=15 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=15 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=15 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=15 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Negative HDV RNA by PCR
|
0 Percentage of participants
Interval 0.0 to 21.8
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
SECONDARY outcome
Timeframe: 24 and 48 weeksPopulation: FAS
Percentage of patients with negative HDV RNA by PCR (undetectable HDV RNA) at Weeks 24 and 48
Outcome measures
| Measure |
Arm A
n=15 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=15 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=15 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=15 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Negative HDV RNA by PCR
Week 24
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
60.0 Percentage of participants
Interval 32.3 to 83.7
|
60.0 Percentage of participants
Interval 32.3 to 83.7
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
66.7 Percentage of participants
Interval 38.4 to 88.2
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
|
Percentage of Patients With Negative HDV RNA by PCR
Week 48
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
80.0 Percentage of participants
Interval 51.9 to 95.7
|
86.7 Percentage of participants
Interval 59.5 to 98.3
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
80 Percentage of participants
Interval 51.9 to 95.7
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
SECONDARY outcome
Timeframe: 24, 48 and 72 weeksPopulation: FAS
Percentage of patients with normalized ALT at Weeks 24, 48 and 72. ALT normalisation was defined as having an ALT value within the normal range (≤31 U/L for females and ≤41 U/L for males)
Outcome measures
| Measure |
Arm A
n=15 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=15 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=15 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=15 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Normalized ALT
Week 24
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
64.3 Percentage of participants
Interval 35.1 to 87.2
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
60.0 Percentage of participants
Interval 32.3 to 83.7
|
|
Percentage of Patients With Normalized ALT
Week 48
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
73.3 Percentage of participants
Interval 44.9 to 92.2
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
|
Percentage of Patients With Normalized ALT
Week 72
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
53.8 Percentage of participants
Interval 25.1 to 80.8
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
35.7 Percentage of participants
Interval 12.08 to 64.9
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
SECONDARY outcome
Timeframe: 24, 48 and 72 weeksPopulation: FAS
Combined response is defined as negative HDV RNA and ALT normalization at Weeks 24, 48, and 72. The criteria for combined response were HDV RNA value below LLoD (where LLoD=10 IU/ml) and ALT within normal range (≤31 U/L for females and ≤41 U/L for males)
Outcome measures
| Measure |
Arm A
n=15 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=15 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=15 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=15 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Combined Response
Week 24
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Patients With Combined Response
Week 48
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Patients With Combined Response
Week 72
|
0 Percentage of participants
Interval 0.0 to 21.8
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
SECONDARY outcome
Timeframe: 24, 48 and 72 weeksPopulation: FAS
HВsAg response was defined as HBsAg negativation or \> 1 log10 IU/mL decline from baseline.
Outcome measures
| Measure |
Arm A
n=15 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=15 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=15 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=15 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With HВsAg Response
Week 24
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Patients With HВsAg Response
Week 48
|
0 Percentage of participants
Interval 0.0 to 21.8
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Patients With HВsAg Response
Week 72
|
0 Percentage of participants
Interval 0.0 to 21.8
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 21.8
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 21.8
|
SECONDARY outcome
Timeframe: 48 and 72 weeksPopulation: According to SAP Section 7.1.5 - Handling of missing data.
Undetectable HВsAg with appearance of HbsAg antibodies or without it.
Outcome measures
| Measure |
Arm A
n=15 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=15 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=15 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=15 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With HBsAg Negativation
Week 48 HBsAg negativation with appearance of HbsAg antibodies
|
0 Percentage of participants
Interval 0.0 to 21.8
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Patients With HBsAg Negativation
Week 72 HBsAg negativation with appearance of HbsAg antibodies
|
0 Percentage of participants
Interval 0.0 to 30.8
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 26.5
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
|
Percentage of Patients With HBsAg Negativation
Week 48 HBsAg negativation without appearance of HbsAg antibodies
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Patients With HBsAg Negativation
Week 72 HBsAg negativation without appearance of HbsAg antibodies
|
0 Percentage of participants
Interval 0.0 to 30.8
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 26.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
SECONDARY outcome
Timeframe: 24, 48 and 72 weeksPercentage of patients with undetectable HBV DNA by PCR at Weeks 24, 48 and 72
Outcome measures
| Measure |
Arm A
n=15 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=15 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=15 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=15 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Negative HBV DNA by PCR
Week 24
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
80.0 Percentage of participants
Interval 51.9 to 95.7
|
|
Percentage of Patients With Negative HBV DNA by PCR
Week 48
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
73.3 Percentage of participants
Interval 44.9 to 92.2
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
66.7 Percentage of participants
Interval 38.4 to 88.2
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
|
Percentage of Patients With Negative HBV DNA by PCR
Week 72
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
66.7 Percentage of participants
Interval 38.4 to 88.2
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
SECONDARY outcome
Timeframe: 48 and 72 weeksPopulation: FAS
Change in liver stiffness and intensity of liver fibrosis based on results of transient elastometry of liver at weeks 48 and 72.
Outcome measures
| Measure |
Arm A
n=13 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=13 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=14 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=9 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.
Change from baseline to Week 48
|
-0.67 kPa
Standard Deviation 2.78
|
1.97 kPa
Standard Deviation 3.94
|
-0.27 kPa
Standard Deviation 3.83
|
-0.66 kPa
Standard Deviation 2.52
|
-2.35 kPa
Standard Deviation 7.47
|
-1.12 kPa
Standard Deviation 3.23
|
|
The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.
Change from baseline to Week 72
|
-0.67 kPa
Standard Deviation 5.25
|
0.65 kPa
Standard Deviation 2.10
|
-2.06 kPa
Standard Deviation 4.49
|
0.00 kPa
Standard Deviation 6.19
|
0.21 kPa
Standard Deviation 6.53
|
-1.20 kPa
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: 72 weeksPopulation: FAS
Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results from baseline to post-treatment Liver fibrosis was evaluated by histological staging systems with stage 0 corresponding to absence of fibrosis and with the highest score (the last stage in all systems) corresponding to cirrhosis. Improvement is defined as a decrease of at least 1 point in histological staging systems; worsening is defined as an increase of at least 1 point. Data should be interpreted with caution due to low number of paired biopsies available.
Outcome measures
| Measure |
Arm A
n=4 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=4 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=4 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=7 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=5 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=14 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Metavir fibrosis stage · Improvement
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Metavir fibrosis stage · Worsening
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Ishak fibrosis score · Improvement
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Ishak fibrosis score · No change
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Ishak fibrosis score · Worsening
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Knodell fibrosis score · Improvement
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Knodell fibrosis score · No change
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Knodell fibrosis score · Worsening
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Metavir fibrosis stage · No change
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Metavir activity grade · Improvement
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Metavir activity grade · No change
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Metavir activity grade · Worsening
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Histological activity index · Improvement
|
2 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Histological activity index · No change
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
Histological activity index · Worsening
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 48 and 72 weeksPopulation: FAS
Molecular analyses of relative HDV RNA expression, relative HBV pregenomic expression, relative total HBV RNA expression (X region), relative HBV RNA expression (S region) from baseline to post-treatment. \*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Outcome measures
| Measure |
Arm A
n=4 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=4 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=3 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=6 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=5 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=14 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).
Relative HDV RNA expression
|
-0.062 Relative value
Standard Deviation 0.097
|
-0.068 Relative value
Standard Deviation 0.145
|
0.296 Relative value
Standard Deviation 0.652
|
-1.220 Relative value
Standard Deviation 1.285
|
-1.676 Relative value
Standard Deviation 2.754
|
-0.975 Relative value
Standard Deviation 1.732
|
|
Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).
Relative HBV pregenomic expression
|
-0.028 Relative value
Standard Deviation 0.044
|
-0.004 Relative value
Standard Deviation 0.007
|
0.003 Relative value
Standard Deviation 0.010
|
-0.001 Relative value
Standard Deviation 0.006
|
-0.041 Relative value
Standard Deviation 0.101
|
0.049 Relative value
Standard Deviation 0.257
|
|
Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).
Relative total HBV RNA expression (X region)
|
0.080 Relative value
Standard Deviation 1.070
|
-1.088 Relative value
Standard Deviation 1.624
|
-1.295 Relative value
Standard Deviation 0.511
|
-0.282 Relative value
Standard Deviation 0.796
|
0.160 Relative value
Standard Deviation 1.380
|
0.403 Relative value
Standard Deviation 1.477
|
|
Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).
Relative HBV RNA expression (S region)
|
-0.688 Relative value
Standard Deviation 1.977
|
-2.295 Relative value
Standard Deviation 2.306
|
-1.696 Relative value
Standard Deviation 1.423
|
-0.451 Relative value
Standard Deviation 0.962
|
0.223 Relative value
Standard Deviation 1.909
|
0.733 Relative value
Standard Deviation 2.372
|
SECONDARY outcome
Timeframe: 48 and 72 weeksPopulation: FAS
Molecular analyses of total HBV DNA (X region) copies/cell, HBV DNA (S region) copies/cell, cccDNA copies/cell from baseline to post-treatment. \*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Outcome measures
| Measure |
Arm A
n=4 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=4 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=3 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=6 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=5 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=14 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.
cccDNA copies/cell
|
-0.045 Copies/cell
Standard Deviation 0.083
|
0.030 Copies/cell
Standard Deviation 0.050
|
0.004 Copies/cell
Standard Deviation 0.042
|
-0.003 Copies/cell
Standard Deviation 0.200
|
-0.117 Copies/cell
Standard Deviation 0.194
|
0.058 Copies/cell
Standard Deviation 0.165
|
|
Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.
Total HBV DNA (X region) copies/cell
|
-0.041 Copies/cell
Standard Deviation 0.215
|
-0.027 Copies/cell
Standard Deviation 0.452
|
-0.132 Copies/cell
Standard Deviation 0.223
|
0.036 Copies/cell
Standard Deviation 0.240
|
-0.297 Copies/cell
Standard Deviation 0.874
|
0.087 Copies/cell
Standard Deviation 0.156
|
|
Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.
HBV DNA (S region) copies/cell
|
-0.413 Copies/cell
Standard Deviation 0.784
|
-0.944 Copies/cell
Standard Deviation 1.265
|
-0.747 Copies/cell
Standard Deviation 1.149
|
0.124 Copies/cell
Standard Deviation 0.954
|
-1.545 Copies/cell
Standard Deviation 3.047
|
0.196 Copies/cell
Standard Deviation 0.517
|
SECONDARY outcome
Timeframe: 48 and 72 weeksPopulation: FAS
Molecular analysis of HDAg positive Hepatocytes (percentage of HDAg positive Hepatocytes) from baseline to post-treatment. \*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Outcome measures
| Measure |
Arm A
n=4 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=3 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=2 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=5 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=5 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=14 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment
Baseline
|
0.757 Percentage
Standard Deviation 0.873
|
2.178 Percentage
Standard Deviation 3.275
|
1.209 Percentage
Standard Deviation 1.001
|
7.550 Percentage
Standard Deviation 7.905
|
12.521 Percentage
Standard Deviation 13.855
|
3.641 Percentage
Standard Deviation 5.919
|
|
Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment
Change from baseline to post-treatment
|
0.099 Percentage
Standard Deviation NA
SD is not available as only one sample from the arm was anlyzed
|
-1.961 Percentage
Standard Deviation 3.439
|
-1.134 Percentage
Standard Deviation 0.995
|
-10.334 Percentage
Standard Deviation 9.041
|
-9.028 Percentage
Standard Deviation 16.100
|
-3.616 Percentage
Standard Deviation 5.923
|
SECONDARY outcome
Timeframe: Weeks 48 - 72Population: FAS
Change in the gene expression analyses of CXCL10, NTCP, CYP7A1, ISG15, MX1, OAS, HLA-E, TAP1 and USP18 from baseline to post-treatment. Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Outcome measures
| Measure |
Arm A
n=4 Participants
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=4 Participants
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=3 Participants
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=4 Participants
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=5 Participants
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=14 Participants
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Change in the Gene Expression Analyses From Baseline to Post-treatment
CYP7A1 relative expression
|
0.002 Relative value
Standard Deviation 0.006
|
0.002 Relative value
Standard Deviation 0.006
|
0.000 Relative value
Standard Deviation 0.001
|
0.001 Relative value
Standard Deviation 0.002
|
-0.001 Relative value
Standard Deviation 0.002
|
0.001 Relative value
Standard Deviation 0.003
|
|
Change in the Gene Expression Analyses From Baseline to Post-treatment
CXCL10 relative expression
|
-0.017 Relative value
Standard Deviation 0.033
|
-0.012 Relative value
Standard Deviation 0.019
|
0.010 Relative value
Standard Deviation 0.005
|
-0.034 Relative value
Standard Deviation 0.009
|
0.003 Relative value
Standard Deviation 0.062
|
-0.015 Relative value
Standard Deviation 0.017
|
|
Change in the Gene Expression Analyses From Baseline to Post-treatment
NTCP relative expression
|
0.001 Relative value
Standard Deviation 0.010
|
-0.016 Relative value
Standard Deviation 0.012
|
0.001 Relative value
Standard Deviation 0.004
|
0.002 Relative value
Standard Deviation 0.005
|
0.011 Relative value
Standard Deviation 0.008
|
0.004 Relative value
Standard Deviation 0.008
|
|
Change in the Gene Expression Analyses From Baseline to Post-treatment
ISG15 relative expression
|
0.207 Relative value
Standard Deviation 0.160
|
-0.092 Relative value
Standard Deviation 0.321
|
-0.003 Relative value
Standard Deviation 0.004
|
-0.037 Relative value
Standard Deviation 0.024
|
-0.163 Relative value
Standard Deviation 0.286
|
-0.005 Relative value
Standard Deviation 0.034
|
|
Change in the Gene Expression Analyses From Baseline to Post-treatment
MX1 relative expression
|
0.175 Relative value
Standard Deviation 0.141
|
-0.020 Relative value
Standard Deviation 0.186
|
-0.013 Relative value
Standard Deviation 0.014
|
-0.034 Relative value
Standard Deviation 0.019
|
-0.056 Relative value
Standard Deviation 0.122
|
-0.000 Relative value
Standard Deviation 0.026
|
|
Change in the Gene Expression Analyses From Baseline to Post-treatment
OAS relative expression
|
0.067 Relative value
Standard Deviation 0.059
|
-0.019 Relative value
Standard Deviation 0.063
|
0.005 Relative value
Standard Deviation 0.009
|
-0.015 Relative value
Standard Deviation 0.010
|
-0.025 Relative value
Standard Deviation 0.049
|
0.003 Relative value
Standard Deviation 0.014
|
|
Change in the Gene Expression Analyses From Baseline to Post-treatment
HLA-E relative expression
|
0.038 Relative value
Standard Deviation 0.095
|
-0.322 Relative value
Standard Deviation 0.175
|
0.015 Relative value
Standard Deviation 0.179
|
-0.386 Relative value
Standard Deviation 0.197
|
0.149 Relative value
Standard Deviation 0.308
|
-0.061 Relative value
Standard Deviation 0.191
|
|
Change in the Gene Expression Analyses From Baseline to Post-treatment
TAP1 relative expression
|
0.000 Relative value
Standard Deviation 0.007
|
-0.012 Relative value
Standard Deviation 0.008
|
-0.001 Relative value
Standard Deviation 0.004
|
-0.017 Relative value
Standard Deviation 0.009
|
0.007 Relative value
Standard Deviation 0.019
|
-0.004 Relative value
Standard Deviation 0.007
|
|
Change in the Gene Expression Analyses From Baseline to Post-treatment
USP18 relative expression
|
0.021 Relative value
Standard Deviation 0.017
|
-0.003 Relative value
Standard Deviation 0.016
|
-0.003 Relative value
Standard Deviation 0.006
|
-0.005 Relative value
Standard Deviation 0.004
|
-0.002 Relative value
Standard Deviation 0.012
|
0.001 Relative value
Standard Deviation 0.003
|
Adverse Events
Arm A
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm B
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm C
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm D
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm E
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm F
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=15 participants at risk
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=15 participants at risk
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=15 participants at risk
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=15 participants at risk
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 participants at risk
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 participants at risk
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
Other adverse events
| Measure |
Arm A
n=15 participants at risk
PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm B
n=15 participants at risk
Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm C
n=15 participants at risk
Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks
|
Arm D
n=15 participants at risk
Myrcludex B 2 mg for 48 weeks
|
Arm E
n=15 participants at risk
Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks
|
Arm F
n=15 participants at risk
Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks
|
|---|---|---|---|---|---|---|
|
Investigations
Total bile acids increased
|
33.3%
5/15 • Number of events 18 • 72 weeks
|
66.7%
10/15 • Number of events 21 • 72 weeks
|
60.0%
9/15 • Number of events 31 • 72 weeks
|
80.0%
12/15 • Number of events 22 • 72 weeks
|
100.0%
15/15 • Number of events 45 • 72 weeks
|
100.0%
15/15 • Number of events 53 • 72 weeks
|
|
Investigations
ALT increased
|
33.3%
5/15 • Number of events 11 • 72 weeks
|
33.3%
5/15 • Number of events 9 • 72 weeks
|
40.0%
6/15 • Number of events 11 • 72 weeks
|
53.3%
8/15 • Number of events 8 • 72 weeks
|
53.3%
8/15 • Number of events 24 • 72 weeks
|
26.7%
4/15 • Number of events 8 • 72 weeks
|
|
Investigations
AST increased
|
33.3%
5/15 • Number of events 11 • 72 weeks
|
26.7%
4/15 • Number of events 8 • 72 weeks
|
26.7%
4/15 • Number of events 6 • 72 weeks
|
53.3%
8/15 • Number of events 8 • 72 weeks
|
40.0%
6/15 • Number of events 19 • 72 weeks
|
26.7%
4/15 • Number of events 5 • 72 weeks
|
|
Investigations
GGT increased
|
26.7%
4/15 • Number of events 9 • 72 weeks
|
26.7%
4/15 • Number of events 7 • 72 weeks
|
20.0%
3/15 • Number of events 5 • 72 weeks
|
26.7%
4/15 • Number of events 5 • 72 weeks
|
53.3%
8/15 • Number of events 16 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Haemoglobin decreased
|
26.7%
4/15 • Number of events 5 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
20.0%
3/15 • Number of events 6 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 8 • 72 weeks
|
13.3%
2/15 • Number of events 4 • 72 weeks
|
|
Investigations
White blood cell count decreased
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 5 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Investigations
C-reactive protein increased
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 8 • 72 weeks
|
13.3%
2/15 • Number of events 4 • 72 weeks
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
20.0%
3/15 • Number of events 6 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Amylase increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
20.0%
3/15 • Number of events 3 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 4 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Investigations
Lipase increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
20.0%
3/15 • Number of events 3 • 72 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 4 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
|
Investigations
Red blood cell sedimentation rate increased
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Weight decreased
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Haematocrit decreased
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Reticulocyte count decreased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Activated partial thromboplastin time shortened
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Blood glucose increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Blood lactate dehydrogenase decreased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Body temperature increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Protein total increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Thyroxine increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Blood and lymphatic system disorders
Neutripenia
|
53.3%
8/15 • Number of events 32 • 72 weeks
|
66.7%
10/15 • Number of events 28 • 72 weeks
|
60.0%
9/15 • Number of events 28 • 72 weeks
|
20.0%
3/15 • Number of events 6 • 72 weeks
|
93.3%
14/15 • Number of events 57 • 72 weeks
|
20.0%
3/15 • Number of events 12 • 72 weeks
|
|
Investigations
Leukopenia
|
60.0%
9/15 • Number of events 25 • 72 weeks
|
53.3%
8/15 • Number of events 21 • 72 weeks
|
46.7%
7/15 • Number of events 19 • 72 weeks
|
26.7%
4/15 • Number of events 8 • 72 weeks
|
93.3%
14/15 • Number of events 58 • 72 weeks
|
26.7%
4/15 • Number of events 12 • 72 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
53.3%
8/15 • Number of events 16 • 72 weeks
|
73.3%
11/15 • Number of events 23 • 72 weeks
|
46.7%
7/15 • Number of events 18 • 72 weeks
|
20.0%
3/15 • Number of events 7 • 72 weeks
|
80.0%
12/15 • Number of events 29 • 72 weeks
|
33.3%
5/15 • Number of events 14 • 72 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
5/15 • Number of events 12 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
33.3%
5/15 • Number of events 10 • 72 weeks
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
3/15 • Number of events 6 • 72 weeks
|
13.3%
2/15 • Number of events 4 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
20.0%
3/15 • Number of events 3 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Blood and lymphatic system disorders
Reticulocytopenia
|
33.3%
5/15 • Number of events 12 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Blood and lymphatic system disorders
Erythropenia
|
26.7%
4/15 • Number of events 7 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Blood and lymphatic system disorders
Reticulocytosis
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 4 • 72 weeks
|
13.3%
2/15 • Number of events 3 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
|
Blood and lymphatic system disorders
Monocytopenia
|
20.0%
3/15 • Number of events 5 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Blood and lymphatic system disorders
Splenic calcification
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
General disorders
Influenza like illness
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
60.0%
9/15 • Number of events 11 • 72 weeks
|
53.3%
8/15 • Number of events 8 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
20.0%
3/15 • Number of events 4 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
General disorders
Asthenia
|
20.0%
3/15 • Number of events 3 • 72 weeks
|
20.0%
3/15 • Number of events 3 • 72 weeks
|
33.3%
5/15 • Number of events 5 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 3 • 72 weeks
|
|
General disorders
Hyperthermia
|
46.7%
7/15 • Number of events 26 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 5 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
General disorders
Injection site erythema
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
20.0%
3/15 • Number of events 8 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
20.0%
3/15 • Number of events 3 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
20.0%
3/15 • Number of events 6 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 3 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
General disorders
Injection site haematoma
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
General disorders
Injection site reaction
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
General disorders
Xerosis
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
General disorders
Chest pain
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 3 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
General disorders
Injection site bruising
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
General disorders
Injection site induration
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
General disorders
Injection site pruritus
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
General disorders
Thirst
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
26.7%
4/15 • Number of events 4 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
3/15 • Number of events 3 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 3 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Metabolism and nutrition disorders
Hypocholesterolaemia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 3 • 72 weeks
|
13.3%
2/15 • Number of events 5 • 72 weeks
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
6.7%
1/15 • Number of events 3 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 5 • 72 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 5 • 72 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Metabolism and nutrition disorders
Hypotriglyceridaemia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Gastrointestinal disorders
Nausea
|
26.7%
4/15 • Number of events 6 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 4 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
|
Gastrointestinal disorders
Gingival bleeding
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Number of events 8 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
13.3%
2/15 • Number of events 3 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 3 • 72 weeks
|
|
Nervous system disorders
Somnolence
|
13.3%
2/15 • Number of events 3 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
33.3%
5/15 • Number of events 7 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
20.0%
3/15 • Number of events 4 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Renal and urinary disorders
Urethral pain
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Infections and infestations
Respiratory track infection
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Infections and infestations
Respiratory track infection viral
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Infections and infestations
Gingivitis
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Hepatobiliary disorders
Hyperbilirubineamia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
6.7%
1/15 • Number of events 4 • 72 weeks
|
20.0%
3/15 • Number of events 7 • 72 weeks
|
13.3%
2/15 • Number of events 4 • 72 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Hepatobiliary disorders
Hepatic calcification
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 4 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
2/15 • Number of events 6 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Fybromyalgia
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Psychiatric disorders
Irritability
|
13.3%
2/15 • Number of events 3 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Psychiatric disorders
Apathy
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Psychiatric disorders
Sleep disorder
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 3 • 72 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Reproductive system and breast disorders
Menstrual disorder
|
13.3%
2/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 3 • 72 weeks
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 2 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Eye disorders
Chalazion
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
0.00%
0/15 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
6.7%
1/15 • Number of events 1 • 72 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60