Trial Outcomes & Findings for A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection (NCT NCT02604212)
NCT ID: NCT02604212
Last Updated: 2026-01-13
Results Overview
Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.
TERMINATED
PHASE2
32 participants
Baseline, Day 113
2026-01-13
Participant Flow
Participant milestones
| Measure |
Placebo High Dose Comparator
Placebo (high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo Low Dose Comparator
Placebo (low dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
11
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
3
|
2
|
Reasons for withdrawal
| Measure |
Placebo High Dose Comparator
Placebo (high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo Low Dose Comparator
Placebo (low dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
1
|
3
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection
Baseline characteristics by cohort
| Measure |
Placebo Low Dose Comparator
n=6 Participants
Placebo (low dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo High Dose Comparator
n=5 Participants
Placebo (high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=10 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=11 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 9.54 • n=210 Participants
|
45.0 years
STANDARD_DEVIATION 10.68 • n=19 Participants
|
42.1 years
STANDARD_DEVIATION 12.57 • n=123 Participants
|
41.6 years
STANDARD_DEVIATION 12.05 • n=123 Participants
|
42.0 years
STANDARD_DEVIATION 10.98 • n=615 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
6 Participants
n=123 Participants
|
10 Participants
n=615 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=210 Participants
|
4 Participants
n=19 Participants
|
10 Participants
n=123 Participants
|
5 Participants
n=123 Participants
|
22 Participants
n=615 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 113Population: Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.
Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=6 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=6 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=8 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113
|
—
|
-0.104 log IU/mL
Standard Error 0.073
|
-0.146 log IU/mL
Standard Error 0.065
|
-0.542 log IU/mL
Standard Error 0.061
|
SECONDARY outcome
Timeframe: Baseline, Days 15, 29, 43, 57, 71, 85, 99Population: Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.
Change From Baseline in log qHBsAg up to Day 99 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=10 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=10 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=10 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Change From Baseline in Log qHBsAg Over Time
Day 15
|
—
|
3.734 log IU/mL
Standard Deviation 0.519
|
3.069 log IU/mL
Standard Deviation 0.654
|
3.000 log IU/mL
Standard Deviation 0.411
|
|
Change From Baseline in Log qHBsAg Over Time
Day 29
|
—
|
3.692 log IU/mL
Standard Deviation 0.588
|
3.148 log IU/mL
Standard Deviation 0.658
|
3.027 log IU/mL
Standard Deviation 0.395
|
|
Change From Baseline in Log qHBsAg Over Time
Day 43
|
—
|
3.812 log IU/mL
Standard Deviation 0.463
|
3.097 log IU/mL
Standard Deviation 0.664
|
2.893 log IU/mL
Standard Deviation 0.436
|
|
Change From Baseline in Log qHBsAg Over Time
Day 57
|
—
|
3.793 log IU/mL
Standard Deviation 0.507
|
3.148 log IU/mL
Standard Deviation 0.651
|
2.882 log IU/mL
Standard Deviation 0.437
|
|
Change From Baseline in Log qHBsAg Over Time
Day 71
|
—
|
3.756 log IU/mL
Standard Deviation 0.489
|
3.088 log IU/mL
Standard Deviation 0.626
|
2.714 log IU/mL
Standard Deviation 0.477
|
|
Change From Baseline in Log qHBsAg Over Time
Day 85
|
—
|
3.743 log IU/mL
Standard Deviation 0.543
|
3.198 log IU/mL
Standard Deviation 0.610
|
2.698 log IU/mL
Standard Deviation 0.466
|
|
Change From Baseline in Log qHBsAg Over Time
Day 99
|
—
|
3.767 log IU/mL
Standard Deviation 0.541
|
3.048 log IU/mL
Standard Deviation 0.593
|
2.606 log IU/mL
Standard Deviation 0.477
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease \> 0 to \< 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease \> 1.0 log IU/mL, tabulated by dose and treatment for each visit.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=10 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=10 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=10 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Change From Baseline at Day 15 in Log qHBsAg, by Category
No Decrease
|
—
|
0.026 log IU/mL
Standard Deviation 0.015
|
—
|
0.032 log IU/mL
Standard Deviation 0.035
|
|
Change From Baseline at Day 15 in Log qHBsAg, by Category
Decrease > 0 to < 0.5 log IU/mL
|
—
|
-0.035 log IU/mL
Standard Deviation 0.014
|
-0.153 log IU/mL
Standard Deviation 0.144
|
-0.266 log IU/mL
Standard Deviation 0.192
|
|
Change From Baseline at Day 15 in Log qHBsAg, by Category
Decrease 0.5 to 1.0 log IU/mL
|
—
|
—
|
-0.707 log IU/mL
Standard Deviation NA
1 participant analyzed
|
-0.666 log IU/mL
Standard Deviation NA
1 participant analyzed
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease \> 0 to \< 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease \> 1.0 log IU/mL, tabulated by dose and treatment for each visit.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=9 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=10 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=10 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Change From Baseline at Day 29 in Log qHBsAg, by Category
No Decrease
|
—
|
0.048 log IU/mL
Standard Deviation 0.043
|
—
|
0.064 log IU/mL
Standard Deviation NA
1 participant analyzed
|
|
Change From Baseline at Day 29 in Log qHBsAg, by Category
Decrease > 0 to < 0.5 log IU/mL
|
—
|
-0.084 log IU/mL
Standard Deviation 0.078
|
-0.129 log IU/mL
Standard Deviation 0.083
|
-0.251 log IU/mL
Standard Deviation 0.190
|
SECONDARY outcome
Timeframe: Baseline, Day 43Population: Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease \> 0 to \< 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease \> 1.0 log IU/mL, tabulated by dose and treatment for each visit.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=8 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=9 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=10 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Change From Baseline at Day 43 in Log qHBsAg, by Category
No Decrease
|
—
|
0.022 log IU/mL
Standard Deviation 0.012
|
—
|
0.017 log IU/mL
Standard Deviation NA
1 participant analyzed
|
|
Change From Baseline at Day 43 in Log qHBsAg, by Category
1 participant analyDecrease > 0 to < 0.5 log IU/mL
|
—
|
-0.050 log IU/mL
Standard Deviation 0.051
|
-0.226 log IU/mL
Standard Deviation 0.077
|
-0.275 log IU/mL
Standard Deviation 0.137
|
|
Change From Baseline at Day 43 in Log qHBsAg, by Category
Decrease 0.5 to 1.0 log IU/mL
|
—
|
—
|
—
|
-0.633 log IU/mL
Standard Deviation 0.141
|
SECONDARY outcome
Timeframe: Baseline, Day 57Population: Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease \> 0 to \< 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease \> 1.0 log IU/mL, tabulated by dose and treatment for each visit.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=7 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=9 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=10 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Change From Baseline at Day 57 in Log qHBsAg, by Category
No Decrease
|
—
|
0.027 log IU/mL
Standard Deviation 0.012
|
—
|
—
|
|
Change From Baseline at Day 57 in Log qHBsAg, by Category
1 participant analyDecrease > 0 to < 0.5 log IU/mL
|
—
|
-0.067 log IU/mL
Standard Deviation 0.072
|
-0.176 log IU/mL
Standard Deviation 0.049
|
-0.276 log IU/mL
Standard Deviation 0.156
|
|
Change From Baseline at Day 57 in Log qHBsAg, by Category
Decrease 0.5 to 1.0 log IU/mL
|
—
|
—
|
—
|
-0.571 log IU/mL
Standard Deviation 0.060
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease \> 0 to \< 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease \> 1.0 log IU/mL, tabulated by dose and treatment for each visit.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=7 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=9 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=9 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Change From Baseline at Day 71 in Log qHBsAg, by Category
No Decrease
|
—
|
0.011 log IU/mL
Standard Deviation 0.012
|
—
|
—
|
|
Change From Baseline at Day 71 in Log qHBsAg, by Category
1 participant analyDecrease > 0 to < 0.5 log IU/mL
|
—
|
-0.094 log IU/mL
Standard Deviation 0.079
|
-0.235 log IU/mL
Standard Deviation 0.086
|
-0.296 log IU/mL
Standard Deviation 0.119
|
|
Change From Baseline at Day 71 in Log qHBsAg, by Category
Decrease 0.5 to 1.0 log IU/mL
|
—
|
—
|
—
|
-0.662 log IU/mL
Standard Deviation 0.140
|
SECONDARY outcome
Timeframe: Baseline, Day 85Population: Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease \> 0 to \< 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease \> 1.0 log IU/mL, tabulated by dose and treatment for each visit.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=7 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=7 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=8 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Change From Baseline at Day 85 in Log qHBsAg, by Category
No Decrease
|
—
|
0.009 log IU/mL
Standard Deviation 0.010
|
—
|
—
|
|
Change From Baseline at Day 85 in Log qHBsAg, by Category
1 participant analyDecrease > 0 to < 0.5 log IU/mL
|
—
|
-0.112 log IU/mL
Standard Deviation 0.147
|
-0.171 log IU/mL
Standard Deviation 0.037
|
-0.293 log IU/mL
Standard Deviation 0.112
|
|
Change From Baseline at Day 85 in Log qHBsAg, by Category
Decrease 0.5 to 1.0 log IU/mL
|
—
|
—
|
—
|
-0.684 log IU/mL
Standard Deviation 0.179
|
SECONDARY outcome
Timeframe: Baseline, Day 99Population: Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease \> 0 to \< 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease \> 1.0 log IU/mL, tabulated by dose and treatment for each visit.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=7 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=6 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=8 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Change From Baseline at Day 99 in Log qHBsAg, by Category
No Decrease
|
—
|
0.027 log IU/mL
Standard Deviation 0.018
|
—
|
—
|
|
Change From Baseline at Day 99 in Log qHBsAg, by Category
1 participant analyDecrease > 0 to < 0.5 log IU/mL
|
—
|
-0.160 log IU/mL
Standard Deviation 0.202
|
-0.210 log IU/mL
Standard Deviation 0.070
|
-0.343 log IU/mL
Standard Deviation 0.110
|
|
Change From Baseline at Day 99 in Log qHBsAg, by Category
Decrease 0.5 to 1.0 log IU/mL
|
—
|
—
|
—
|
-0.652 log IU/mL
Standard Deviation 0.068
|
|
Change From Baseline at Day 99 in Log qHBsAg, by Category
Decrease > 1.0 log IU/mL
|
—
|
—
|
—
|
-1.011 log IU/mL
Standard Deviation NA
1 participant analyzed
|
SECONDARY outcome
Timeframe: Baseline, Day 113Population: Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease \> 0 to \< 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease \> 1.0 log IU/mL, tabulated by dose and treatment for each visit.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=6 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=6 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=8 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Change From Baseline at Day 113 in Log qHBsAg, by Category
No Decrease
|
—
|
0.042 log IU/mL
Standard Deviation NA
1 participant analyzed
|
—
|
—
|
|
Change From Baseline at Day 113 in Log qHBsAg, by Category
Decrease 0.5 to 1.0 log IU/mL
|
—
|
—
|
—
|
-0.726 log IU/mL
Standard Deviation 0.228
|
|
Change From Baseline at Day 113 in Log qHBsAg, by Category
1 participant analyDecrease > 0 to < 0.5 log IU/mL
|
—
|
-0.115 log IU/mL
Standard Deviation 0.171
|
-0.142 log IU/mL
Standard Deviation 0.045
|
-0.359 log IU/mL
Standard Deviation 0.049
|
SECONDARY outcome
Timeframe: Through Day 169 (± 3 days)Population: Safety Population: all participants who received at least one dose of study drug or placebo, and had at least one post-dose safety assessment.
An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. A treatment emergent AE (TEAE) was defined as an AE that was not present prior to the first study drug administration and started at/after the time of initiation of administration of study drug, or an AE which was present prior to initiation of study drug administration, which increased in severity after study drug administration. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
Outcome measures
| Measure |
ARC-520 2.0 mg/kg
n=11 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo
n=6 Participants
Placebo (low dose or high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=5 Participants
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=10 Participants
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
≥ 1 TEAE
|
3 participants
|
4 participants
|
0 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
≥ 1 Serious TEAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
≥ 1 AE
|
3 participants
|
4 participants
|
0 participants
|
6 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
≥ 1 TEAE Leading to Study Discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
≥ 1 TEAE Leading to Treatment Discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Through 48 hours post-dosing on Day 1 and Day 85Population: Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 48 hours post-dosing on Day 1 and Day 85Population: Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 48 hours post-dosing on Day 1 and Day 85Population: Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 48 hours post-dosing on Day 1 and Day 85Population: Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 48 hours post-dosing on Day 1 and Day 85Population: Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 48 hours post-dosing on Day 1 and Day 85Population: Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 48 hours post-dosing on Day 1 and Day 85Population: Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 48 hours post-dosing on Day 1 and Day 85Population: Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.
Outcome measures
Outcome data not reported
Adverse Events
Placebo Low Dose Comparator
Placebo High Dose Comparator
ARC-520 1.0 mg/kg
ARC-520 2.0 mg/kg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Low Dose Comparator
n=6 participants at risk
Placebo (low dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
Placebo High Dose Comparator
n=5 participants at risk
Placebo (high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 1.0 mg/kg
n=10 participants at risk
Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
ARC-520 2.0 mg/kg
n=11 participants at risk
High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
General disorders
Asthenia
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
9.1%
1/11 • Through Day 169 (± 3 days)
|
|
General disorders
Chills
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
General disorders
Discomfort
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
General disorders
Fatigue
|
16.7%
1/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
9.1%
1/11 • Through Day 169 (± 3 days)
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
9.1%
1/11 • Through Day 169 (± 3 days)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
9.1%
1/11 • Through Day 169 (± 3 days)
|
|
Investigations
Eosinophil count increased
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
9.1%
1/11 • Through Day 169 (± 3 days)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
10.0%
1/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Through Day 169 (± 3 days)
|
0.00%
0/5 • Through Day 169 (± 3 days)
|
0.00%
0/10 • Through Day 169 (± 3 days)
|
0.00%
0/11 • Through Day 169 (± 3 days)
|
Additional Information
Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place