Trial Outcomes & Findings for Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection (NCT NCT02738008)
NCT ID: NCT02738008
Last Updated: 2026-01-13
Results Overview
Initial responders are defined as participants who showed a ½ log or greater reduction in their serum HBsAg levels from baseline to Day 71 ± 3 days of the primary Heparc-2002 and Heparc-2003 studies, where baseline is defined as the average of pre-dose values.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline, Week 36
Results posted on
2026-01-13
Participant Flow
This study was conducted in participants who successfully completed the primary studies Heparc-2002 (NCT02604199) and Heparc-2003 (NCT02604212) through Day 113 and responded to therapy, except for those who achieved loss of Hepatitis B Surface Antigen (HBsAg) during the primary study.
No participants were enrolled from the Heparc-2002 or Heparc-2003 placebo groups.
Participant milestones
| Measure |
Heparc-2002: ARC-520 1.0 mg/kg
ARC-520 2.0 mg/kg administered by intravenous (IV) infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 1.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Heparc-2002: ARC-520 2.0 mg/kg
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Heparc-2003: ARC-520 2.0 mg/kg
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2003 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
6
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
5
|
Reasons for withdrawal
| Measure |
Heparc-2002: ARC-520 1.0 mg/kg
ARC-520 2.0 mg/kg administered by intravenous (IV) infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 1.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Heparc-2002: ARC-520 2.0 mg/kg
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Heparc-2003: ARC-520 2.0 mg/kg
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2003 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
5
|
3
|
Baseline Characteristics
Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection
Baseline characteristics by cohort
| Measure |
Heparc-2002: ARC-520 1.0 mg/kg
n=1 Participants
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 1.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Heparc-2002: ARC-520 2.0 mg/kg
n=6 Participants
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Heparc-2003: ARC-520 2.0 mg/kg
n=5 Participants
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2003 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=210 Participants
|
5 Participants
n=19 Participants
|
5 Participants
n=123 Participants
|
11 Participants
n=123 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=210 Participants
|
5 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
7 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
3 Participants
n=123 Participants
|
5 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 36Population: The study was terminated prior to any participant reaching Week 36 of treatment; therefore, this outcome measure could not be analyzed.
Initial responders are defined as participants who showed a ½ log or greater reduction in their serum HBsAg levels from baseline to Day 71 ± 3 days of the primary Heparc-2002 and Heparc-2003 studies, where baseline is defined as the average of pre-dose values.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-upPopulation: Safety Population: all participants who received at least 1 dose of study medication and had at least 1 post-dose safety assessment.
An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: 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; or is a medically important event or reaction. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
Outcome measures
| Measure |
Heparc-2003: ARC-520 2.0 mg/kg
n=5 Participants
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2003 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Heparc-2002: ARC-520 1.0 mg/kg
n=1 Participants
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 1.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Heparc-2002: ARC-520 2.0 mg/kg
n=6 Participants
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
AEs
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 36, 48, and 60Population: The study was terminated prior to any participant reaching Week 36 of treatment; therefore, this outcome measure could not be analyzed.
The qualitative HBsAg assay gives a binary result, positive or negative. Baseline is defined as the average of the pre-dose values in the primary Heparc-2002 and Heparc-2003 studies.
Outcome measures
Outcome data not reported
Adverse Events
Heparc-2002: ARC-520 1.0 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Heparc-2002: ARC-520 2.0 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Heparc-2003: ARC-520 2.0 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Heparc-2002: ARC-520 1.0 mg/kg
n=1 participants at risk
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 1.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Heparc-2002: ARC-520 2.0 mg/kg
n=6 participants at risk
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
Heparc-2003: ARC-520 2.0 mg/kg
n=5 participants at risk
ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2003 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
40.0%
2/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
40.0%
2/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
General disorders
Chest discomfort
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
40.0%
2/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
General disorders
Chills
|
100.0%
1/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
General disorders
Fatigue
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
20.0%
1/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
General disorders
Malaise
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
16.7%
1/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
General disorders
Pyrexia
|
100.0%
1/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
20.0%
1/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
16.7%
1/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
16.7%
1/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
1/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
Nervous system disorders
Hyposaesthesia
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
16.7%
1/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
16.7%
1/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
16.7%
1/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
16.7%
1/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
0.00%
0/6 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
40.0%
2/5 • From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
|
Additional Information
Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Phone: 626-304-3400
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place