Trial Outcomes & Findings for A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D (NCT NCT03546621)
NCT ID: NCT03546621
Last Updated: 2021-05-10
Results Overview
HDV RNA negativation or decrease by ≥2 log10 from baseline to Week 24
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
24 weeks
Results posted on
2021-05-10
Participant Flow
Of 120 randomized patients 118 started treatment with study medication (2 patients from Tenofovir only group withdrew before treatment)
Participant milestones
| Measure |
Arm A
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
32
|
30
|
28
|
|
Overall Study
COMPLETED
|
28
|
29
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
2
|
3
|
Reasons for withdrawal
| Measure |
Arm A
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
|
Overall Study
Progressive disease
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D
Baseline characteristics by cohort
| Measure |
Arm A
n=28 Participants
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 Participants
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 Participants
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 Participants
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Total
n=118 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
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
118 Participants
n=21 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
|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
41.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
40.2 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
79 Participants
n=21 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
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
101 Participants
n=21 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
|
|
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
|
|
Height (cm)
|
168.5 cm.
STANDARD_DEVIATION 8.3 • n=5 Participants
|
172.9 cm.
STANDARD_DEVIATION 7.4 • n=7 Participants
|
173.8 cm.
STANDARD_DEVIATION 9.8 • n=5 Participants
|
172.8 cm.
STANDARD_DEVIATION 9.4 • n=4 Participants
|
172.0 cm.
STANDARD_DEVIATION 8.9 • n=21 Participants
|
|
Body Weight (kg)
|
70.19 kg.
STANDARD_DEVIATION 13.54 • n=5 Participants
|
75.09 kg.
STANDARD_DEVIATION 12.54 • n=7 Participants
|
77.59 kg.
STANDARD_DEVIATION 13.72 • n=5 Participants
|
79.15 kg.
STANDARD_DEVIATION 17.21 • n=4 Participants
|
75.53 kg.
STANDARD_DEVIATION 14.49 • n=21 Participants
|
|
Body Mass Index (kg/m²)
<30 kg/m²
|
27 participants
n=5 Participants
|
31 participants
n=7 Participants
|
28 participants
n=5 Participants
|
22 participants
n=4 Participants
|
108 participants
n=21 Participants
|
|
Body Mass Index (kg/m²)
≥30 kg/m²
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
10 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: mITT
HDV RNA negativation or decrease by ≥2 log10 from baseline to Week 24
Outcome measures
| Measure |
Arm A
n=28 Participants
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 Participants
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 Participants
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 Participants
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
HDV RNA Response at Week 24
Responder
|
15 Participants
|
16 Participants
|
23 Participants
|
1 Participants
|
|
HDV RNA Response at Week 24
Non-Responder
|
13 Participants
|
16 Participants
|
7 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: mITT
Durability of HDV RNA response to 24 weeks post treatment
Outcome measures
| Measure |
Arm A
n=28 Participants
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 Participants
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 Participants
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 Participants
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Durability of HDV RNA Response
Response at Week 24 only
|
15 Participants
|
16 Participants
|
23 Participants
|
1 Participants
|
|
Durability of HDV RNA Response
Response at Week 24 and 48
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: mITT
Combined response: HDV RNA negativation or ≥2 log decline and normal ALT at treatment week 24
Outcome measures
| Measure |
Arm A
n=28 Participants
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 Participants
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 Participants
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 Participants
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24
Week 24 · Responder
|
6 Participants
|
9 Participants
|
11 Participants
|
0 Participants
|
|
Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24
Week 24 · Non-Responder
|
22 Participants
|
23 Participants
|
19 Participants
|
28 Participants
|
|
Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24
Week 48 · Responder
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24
Week 48 · Non-Responder
|
26 Participants
|
31 Participants
|
29 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 24 and 48 weeksPopulation: mITT
Changes in ALT values at Week 24 and Week 48 compared to baseline.
Outcome measures
| Measure |
Arm A
n=28 Participants
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 Participants
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 Participants
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 Participants
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Changes in ALT Values
Change from Baseline to Week 24
|
-49.6 U/L
Standard Deviation 58.7
|
-79.4 U/L
Standard Deviation 84.2
|
-78.9 U/L
Standard Deviation 81.1
|
-29.2 U/L
Standard Deviation 61.4
|
|
Changes in ALT Values
Change from Baseline to Week 48
|
-1.6 U/L
Standard Deviation 72.8
|
-18.2 U/L
Standard Deviation 94.4
|
1.4 U/L
Standard Deviation 76.0
|
-26.3 U/L
Standard Deviation 39.0
|
SECONDARY outcome
Timeframe: 24 and 48 weeksPopulation: mITT
Change (absence of increase) in fibrosis marker: serum alpha-2-macroglobulin at Week 24 and Week 48 compared to baseline
Outcome measures
| Measure |
Arm A
n=28 Participants
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 Participants
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 Participants
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 Participants
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Change (Absence of Increase) in Fibrosis Marker
Change from Baseline to Week 24
|
-0.076 g/L
Standard Deviation 0.320
|
0.020 g/L
Standard Deviation 0.280
|
0.024 g/L
Standard Deviation 0.257
|
-0.141 g/L
Standard Deviation 0.607
|
|
Change (Absence of Increase) in Fibrosis Marker
Change from Baseline to Week 48
|
-0.056 g/L
Standard Deviation 0.416
|
0.075 g/L
Standard Deviation 0.360
|
-0.008 g/L
Standard Deviation 0.265
|
-0.031 g/L
Standard Deviation 0.485
|
SECONDARY outcome
Timeframe: 24 and 48 weeksPopulation: mITT
Changes in hepatitis B surface antigen (HBsAg) (defined as decline in HBsAg levels, disappearance of HBsAg and HBsAg seroconversion to anti-HBsAg) at week 24 and week 48 compared to baseline
Outcome measures
| Measure |
Arm A
n=28 Participants
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 Participants
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 Participants
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 Participants
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Change in Hepatitis B Surface Antigen
Change from Baseline to Week 24
|
-0.048 IU/mL
Standard Deviation 0.392
|
0.003 IU/mL
Standard Deviation 0.175
|
0.034 IU/mL
Standard Deviation 0.106
|
0.025 IU/mL
Standard Deviation 0.239
|
|
Change in Hepatitis B Surface Antigen
Change from Baseline to Week 48
|
-0.138 IU/mL
Standard Deviation 0.288
|
-0.162 IU/mL
Standard Deviation 0.412
|
-0.134 IU/mL
Standard Deviation 0.175
|
-0.070 IU/mL
Standard Deviation 0.186
|
SECONDARY outcome
Timeframe: 24 and 48 weeksPopulation: mITT
Change in hepatitis B virus (HBV) DNA levels at Week 24 and Week 48 compared to baseline.
Outcome measures
| Measure |
Arm A
n=28 Participants
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 Participants
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 Participants
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 Participants
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline
Change from Baseline to Week 24
|
-0.314 IU/mL
Standard Deviation 0.956
|
-0.484 IU/mL
Standard Deviation 1.106
|
-0.173 IU/mL
Standard Deviation 1.144
|
-0.343 IU/mL
Standard Deviation 1.151
|
|
Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline
Change from Baseline to Week 48
|
-0.244 IU/mL
Standard Deviation 0.828
|
-0.194 IU/mL
Standard Deviation 1.416
|
-0.267 IU/mL
Standard Deviation 1.275
|
-0.257 IU/mL
Standard Deviation 0.979
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: mITT
Decrease in liver stiffness and absence of a fibrosis progression according to the findings of transient elastometry (fibroscan) at week 24 compared to baseline
Outcome measures
| Measure |
Arm A
n=28 Participants
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 Participants
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 Participants
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 Participants
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Absence of a Fibrosis Progression According to the Findings of Transient Elastometry
Baseline
|
14.45 kPa
Standard Deviation 6.37
|
17.18 kPa
Standard Deviation 11.49
|
16.00 kPa
Standard Deviation 7.37
|
16.20 kPa
Standard Deviation 7.83
|
|
Absence of a Fibrosis Progression According to the Findings of Transient Elastometry
Change from Baseline to Week 24
|
-2.85 kPa
Standard Deviation 2.65
|
-2.52 kPa
Standard Deviation 6.21
|
-3.38 kPa
Standard Deviation 3.83
|
-0.78 kPa
Standard Deviation 3.17
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: mITT
Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results at week 24 compared to baseline. 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=7 Participants
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=5 Participants
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=7 Participants
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=4 Participants
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Ishak fibrosis score · Improvement
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Ishak fibrosis score · No change
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Ishak fibrosis score · Worsening
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Knodell fibrosis score · Improvement
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Knodell fibrosis score · No change
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Knodell fibrosis score · Worsening
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Metavir fibrosis stage · Improvement
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Metavir fibrosis stage · No change
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Metavir fibrosis stage · Worsening
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Metavir activity grade · Improvement
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Metavir activity grade · No change
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Metavir activity grade · Worsening
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Histological activity index · Improvement
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Histological activity index · No change
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
Histological activity index · Worsening
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Arm A
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Arm B
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Arm C
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm D
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=28 participants at risk
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 participants at risk
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 participants at risk
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 participants at risk
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Investigations
ALT increased
|
0.00%
0/28 • 48 weeks
|
6.2%
2/32 • Number of events 2 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
Other adverse events
| Measure |
Arm A
n=28 participants at risk
Myrcludex B, 2 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex B: 2 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm B
n=32 participants at risk
Myrcludex B, 5 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 5 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm C
n=30 participants at risk
Myrcludex B, 10 mg/day subcutaneously (s.c.) for 24 weeks + tenofovir with a further follow-up period of 24 weeks of continued tenofovir therapy.
Myrcludex-B: 10 mg, once daily, subcutaneously
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
Arm D
n=28 participants at risk
tenofovir treatment for 48 weeks
Tenofovir: tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
|
|---|---|---|---|---|
|
Investigations
Total bile acids increased
|
28.6%
8/28 • Number of events 12 • 48 weeks
|
37.5%
12/32 • Number of events 20 • 48 weeks
|
50.0%
15/30 • Number of events 24 • 48 weeks
|
21.4%
6/28 • Number of events 8 • 48 weeks
|
|
Investigations
ALT increased
|
14.3%
4/28 • Number of events 4 • 48 weeks
|
15.6%
5/32 • Number of events 9 • 48 weeks
|
30.0%
9/30 • Number of events 12 • 48 weeks
|
14.3%
4/28 • Number of events 10 • 48 weeks
|
|
Investigations
AST increased
|
10.7%
3/28 • Number of events 3 • 48 weeks
|
21.9%
7/32 • Number of events 10 • 48 weeks
|
26.7%
8/30 • Number of events 12 • 48 weeks
|
10.7%
3/28 • Number of events 4 • 48 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.7%
3/28 • Number of events 3 • 48 weeks
|
15.6%
5/32 • Number of events 10 • 48 weeks
|
6.7%
2/30 • Number of events 5 • 48 weeks
|
10.7%
3/28 • Number of events 4 • 48 weeks
|
|
General disorders
Fatigue
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
6.2%
2/32 • Number of events 2 • 48 weeks
|
16.7%
5/30 • Number of events 6 • 48 weeks
|
7.1%
2/28 • Number of events 2 • 48 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
12.5%
4/32 • Number of events 4 • 48 weeks
|
10.0%
3/30 • Number of events 11 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
12.5%
4/32 • Number of events 8 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
10.7%
3/28 • Number of events 4 • 48 weeks
|
|
Nervous system disorders
Dizziness
|
7.1%
2/28 • Number of events 2 • 48 weeks
|
6.2%
2/32 • Number of events 2 • 48 weeks
|
10.0%
3/30 • Number of events 4 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 3 • 48 weeks
|
6.2%
2/32 • Number of events 2 • 48 weeks
|
10.0%
3/30 • Number of events 3 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
4/28 • Number of events 4 • 48 weeks
|
6.2%
2/32 • Number of events 4 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Investigations
GGT increased
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
6.7%
2/30 • Number of events 2 • 48 weeks
|
10.7%
3/28 • Number of events 3 • 48 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.7%
3/28 • Number of events 3 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
Lipase increased
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
3.1%
1/32 • Number of events 2 • 48 weeks
|
6.7%
2/30 • Number of events 6 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
Amylase increased
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
6.7%
2/30 • Number of events 4 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
Haemoglobin decreased
|
7.1%
2/28 • Number of events 3 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Investigations
Neutrophil count decreased
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
INR increased
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
White blood cell count decreased
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
Reticulocyte count decreased
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 3 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
ECG abnormal
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Investigations
APTT prolonged
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
3.1%
1/32 • Number of events 4 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/28 • 48 weeks
|
6.2%
2/32 • Number of events 2 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
7.1%
2/28 • Number of events 2 • 48 weeks
|
|
Blood and lymphatic system disorders
Eosiniphilia
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Blood and lymphatic system disorders
Monocytopenia
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
General disorders
Injection site erythema
|
7.1%
2/28 • Number of events 2 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
6.7%
2/30 • Number of events 3 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Influenza like illness
|
7.1%
2/28 • Number of events 4 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Hyperthermia
|
7.1%
2/28 • Number of events 2 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 2 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Injection site pruritus
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
3.3%
1/30 • Number of events 3 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Injection site haematoma
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Asthenia
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Chest pain
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Discomfort
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Injection sire paraesthesia
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Injection site reaction
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Thirst
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
6.2%
2/32 • Number of events 2 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
3.6%
1/28 • Number of events 2 • 48 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 2 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Nervous system disorders
Presyncope
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Nervous system disorders
Somnolence
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
6.2%
2/32 • Number of events 2 • 48 weeks
|
6.7%
2/30 • Number of events 3 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Infections and infestations
Infected bite
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Infections and infestations
Influenza
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Infections and infestations
Respiratory tract infection
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
2/28 • Number of events 2 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
6.7%
2/30 • Number of events 2 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 2 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/28 • 48 weeks
|
6.2%
2/32 • Number of events 2 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
6.7%
2/30 • Number of events 2 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Vascular disorders
Haematoma
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Eye disorders
Eye pain
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Immune system disorders
Perfume sensitivity
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Surgical and medical procedures
Oesophageal variceal ligation
|
0.00%
0/28 • 48 weeks
|
3.1%
1/32 • Number of events 1 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
0.00%
0/28 • 48 weeks
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/28 • 48 weeks
|
0.00%
0/32 • 48 weeks
|
0.00%
0/30 • 48 weeks
|
3.6%
1/28 • Number of events 1 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60