Hepatitis BPhase 2NCT02604212
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection
A Phase 2 study testing ARC-520, entecavir and antihistamine in people with Hepatitis B, run by Arrowhead Pharmaceuticals at 16 sites in 3 countries.
Trial summary
Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- ARC-520, entecavir and antihistamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Nov 2015to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 75 years of age.
- Written informed consent.
- No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment.
- No new abnormal finding of clinical relevance at the screening evaluation.
- Diagnosis of HBeAg positive, immune active, chronic HBV infection.
- > 2months of continuous treatment with daily, oral entecavir or tenofovir.
- Willingness to continue taking entecavir or tenofovir throughout the study.
- Must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners).
Who cannot join
- Pregnant or lactating
- Acute signs of hepatitis/other infection within 4 weeks of screening.
- Antiviral therapy other than entecavir or tenofovir within 3 months of screening.
- Prior treatment with interferon in the last 3 years.
- Use within the last 6 months or anticipated requirement for anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
- Use of prescription medication within 14 days prior to treatment administration except: topical products without systemic absorption, statins (except rosuvastatin), hypertension medications, or hormonal contraceptives.
Show all 33Show fewer
- Depot injection or implant of any drug within 3 months prior to treatment administration, except injectable/implantable birth control.
- Diagnosis of diabetes mellitus.
- History of autoimmune disease especially autoimmune hepatitis.
- Human immunodeficiency virus (HIV) infection.
- Sero-positive for Hepatitis C Virus (HCV), and/or a history of delta virus hepatitis.
- Hypertension defined as blood pressure > 150/100 mmHg.
- History of cardiac rhythm disturbances.
- Family history or congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
- Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease within 6 months prior to study entry.
- History of malignancy except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer.
- Has had a major surgery within 3 months of screening.
- History of alcohol and/or drug abuse < 12 months from screening.
- Regular uses of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week).
- Evidence of severe systemic acute inflammation, sepsis, or hemolysis.
- Diagnosed with a significant psychiatric disorder.
- Use of recreational drugs, such as marijuana, within 3 months prior to screening.
- Use of drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to screening.
- History of allergy to bee sting.
- Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.
- Clinically significant history or presence of any gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease.
- Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction.
- Clinically significant history or presence of poorly controlled/uncontrolled systemic disease.
- History of fever within 2 weeks of screening.
- Immunized with a live attenuated vaccine within 7 days prior to dosing or planned vaccination (excluding flu vaccine by injection).
- Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk.
- Participated in excessive exercise/physical activity within 7 days of screening or planned during the trial.
- History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s).
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Germany9 sites
Research Site 11
Frankfurt, 60590
Research Site 9
Hamburg, 20099
Research Site 8
Hanover, 30625
Research Site 10
Leipzig, 04103
Research Site 4
Leipzig, 4103
Research Site 5
München, 81377
Research Site 3
Tübingen, 72076
Research Site 6
Ulm, 89081
Research Site 7
Würzburg, 97080
South Korea5 sites
Research Site 13
Busan, 602-739
Research Site 15
Incheon, 405-760
Research Site 14
Seoul, 110-744
Research Site 16
Seoul, 120-752
Research Site 12
Yangsan-si Gyeongnam, 626-770
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With HBeAg Positive, Chronic Hepatitis B Virus (HBV) Infection
Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, multi-dose study of ARC-520 in combination with entecavir or tenofovir administered to patients with HBeAg positive and immune active chronic HBV infection Eligible patients who have signed an Ethics Committee - approved informed consent, will be enrolled and will receive ARC-520 or placebo in combination with entecavir or tenofovir. The study will enroll up to a total of 90 eligible chronic HBV infected patients. Patients will undergo the following evaluations at regular intervals during the study: medical history, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate and temperature), weight, adverse events assessment (AEs), 12 lead electrocardiograms (ECGs), liver fibrosis testing, concomitant medication assessment, blood sample collection for hematology, coagulation, chemistry, lactate, Pharmacokinetic (PK) measures (in a subset of patients), exploratory Pharmacodynamic (PD) measures, urinalysis, HBV serology, Follicle Stimulating Hormone (FSH) testing (post-menopausal females) and pregnancy testing for females of childbearing potential. Clinically significant changes including AEs will be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or until the patient is lost to follow-up. For each patient the duration of the study is approximately 33 weeks from screening to the Day 169 follow-up visit. For patients enrolling into a planned extension study, the total duration of this study is approximately 25 weeks from screening to Day 113 end of study visit.
- Conditions
- Hepatitis B
- Being tested
- ARC-520, Placebo, entecavir, antihistamine, tenofovir
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-520Drug
PlaceboOther
entecavirDrug
All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.
antihistamineDrug
All participants will be pretreated with an oral antihistamine. The antihistamine used should in general be an H1>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg. The Investigator is free to choose any of these antihistamines available locally and consistent with their country's Marketing Authorisation.
tenofovirDrug
All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Low Dose Comparator | Placebo 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) Receives: Other: Placebo; Drug: entecavir; Drug: antihistamine; Drug: tenofovir |
| Placebo High Dose Comparator | Placebo 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) Receives: Other: Placebo; Drug: entecavir; Drug: antihistamine; Drug: tenofovir |
| ARC-520 1.0 mg/kg | Experimental | 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) Receives: Drug: ARC-520; Drug: entecavir; Drug: antihistamine; Drug: tenofovir |
| ARC-520 2.0 mg/kg | Experimental | 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) Receives: Drug: ARC-520; Drug: entecavir; Drug: antihistamine; Drug: tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113
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.
Measured: Baseline, Day 113
Secondary outcomes (18)
Change From Baseline in Log qHBsAg Over Time
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.
Measured: Baseline, Days 15, 29, 43, 57, 71, 85, 99
Change From Baseline at Day 15 in Log qHBsAg, by Category
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.
Measured: Baseline, Day 15
Change From Baseline at Day 29 in Log qHBsAg, by Category
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.
Measured: Baseline, Day 29
Change From Baseline at Day 43 in Log qHBsAg, by Category
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.
Measured: Baseline, Day 43
Change From Baseline at Day 57 in Log qHBsAg, by Category
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.
Measured: Baseline, Day 57
Change From Baseline at Day 71 in Log qHBsAg, by Category
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.
Measured: Baseline, Day 71
Change From Baseline at Day 85 in Log qHBsAg, by Category
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.
Measured: Baseline, Day 85
Change From Baseline at Day 99 in Log qHBsAg, by Category
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.
Measured: Baseline, Day 99
Change From Baseline at Day 113 in Log qHBsAg, by Category
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.
Measured: Baseline, Day 113
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
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.
Measured: Through Day 169 (± 3 days)
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
Measured: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)
Measured: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)
Measured: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)
Measured: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Clearance (CL)
Measured: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)
Measured: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)
Measured: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)
Measured: Through 48 hours post-dosing on Day 1 and Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Company decision to discontinue trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604212
- Sponsor's protocol ID
- Heparc-2003
- Other IDs
- 2014-004751-31, 2014
- Status last verified
- Dec 2025
- First submitted
- 11 Nov 2015
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With HBeAg Positive, Chronic Hepatitis B Virus (HBV) Infection
- ClinicalTrials.gov ID
- NCT02604212
- Acronym / sponsor ID
- Heparc-2003
- Conditions
- Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision to discontinue trial
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, multi-dose study of ARC-520 in combination with entecavir or tenofovir administered to patients with HBeAg positive and immune active chronic HBV infection Eligible patients who have signed an Ethics Committee - approved informed consent, will be enrolled and will receive ARC-520 or placebo in combination with entecavir or tenofovir. The study will enroll up to a total of 90 eligible chronic HBV infected patients. Patients will undergo the following evaluations at regular intervals during the study: medical history, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate and temperature), weight, adverse events assessment (AEs), 12 lead electrocardiograms (ECGs), liver fibrosis testing, concomitant medication assessment, blood sample collection for hematology, coagulation, chemistry, lactate, Pharmacokinetic (PK) measures (in a subset of patients), exploratory Pharmacodynamic (PD) measures, urinalysis, HBV serology, Follicle Stimulating Hormone (FSH) testing (post-menopausal females) and pregnancy testing for females of childbearing potential. Clinically significant changes including AEs will be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or until the patient is lost to follow-up. For each patient the duration of the study is approximately 33 weeks from screening to the Day 169 follow-up visit. For patients enrolling into a planned extension study, the total duration of this study is approximately 25 weeks from screening to Day 113 end of study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Low Dose Comparator | Placebo comparator | Other: Placebo, Drug: entecavir, Drug: antihistamine, Drug: tenofovirPlacebo (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 | Placebo comparator | Other: Placebo, Drug: entecavir, Drug: antihistamine, Drug: tenofovirPlacebo (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 | Experimental | Drug: ARC-520, Drug: entecavir, Drug: antihistamine, Drug: tenofovirLow 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 | Experimental | Drug: ARC-520, Drug: entecavir, Drug: antihistamine, Drug: tenofovirHigh 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, 18 to 75 years of age.
- Written informed consent.
- No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment.
- No new abnormal finding of clinical relevance at the screening evaluation.
- Diagnosis of HBeAg positive, immune active, chronic HBV infection.
Key exclusion criteria (33 listed)
- Pregnant or lactating
- Acute signs of hepatitis/other infection within 4 weeks of screening.
- Antiviral therapy other than entecavir or tenofovir within 3 months of screening.
- Prior treatment with interferon in the last 3 years.
- Use within the last 6 months or anticipated requirement for anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARC-520 | Drug | ARC-520 1.0 mg/kg, ARC-520 2.0 mg/kg |
| Placebo | Other | Placebo High Dose Comparator, Placebo Low Dose Comparator |
| entecavirAll participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily. | Drug | ARC-520 1.0 mg/kg, ARC-520 2.0 mg/kg, Placebo High Dose Comparator, Placebo Low Dose Comparator |
| antihistamineAll participants will be pretreated with an oral antihistamine. The antihistamine used should in general be an H1>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg. The Investigator is free to choose any of these antihistamines available locally and consistent with their country's Marketing Authorisation. | Drug | ARC-520 1.0 mg/kg, ARC-520 2.0 mg/kg, Placebo High Dose Comparator, Placebo Low Dose Comparator |
| tenofovirAll participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily. | Drug | ARC-520 1.0 mg/kg, ARC-520 2.0 mg/kg, Placebo High Dose Comparator, Placebo Low Dose Comparator |
Primary outcome
Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113
Time frame: Baseline, Day 113
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.
18 secondary outcomes
Change From Baseline in Log qHBsAg Over Time
Time frame: Baseline, Days 15, 29, 43, 57, 71, 85, 99
Change From Baseline at Day 15 in Log qHBsAg, by Category
Time frame: Baseline, Day 15
Change From Baseline at Day 29 in Log qHBsAg, by Category
Time frame: Baseline, Day 29
Change From Baseline at Day 43 in Log qHBsAg, by Category
Time frame: Baseline, Day 43
Change From Baseline at Day 57 in Log qHBsAg, by Category
Time frame: Baseline, Day 57
Change From Baseline at Day 71 in Log qHBsAg, by Category
Time frame: Baseline, Day 71
Change From Baseline at Day 85 in Log qHBsAg, by Category
Time frame: Baseline, Day 85
Change From Baseline at Day 99 in Log qHBsAg, by Category
Time frame: Baseline, Day 99
Change From Baseline at Day 113 in Log qHBsAg, by Category
Time frame: Baseline, Day 113
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
Time frame: Through Day 169 (± 3 days)
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
Time frame: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)
Time frame: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)
Time frame: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)
Time frame: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Clearance (CL)
Time frame: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)
Time frame: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)
Time frame: Through 48 hours post-dosing on Day 1 and Day 85
Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)
Time frame: Through 48 hours post-dosing on Day 1 and Day 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARC-520, entecavir and antihistamine in people with Hepatitis B, run by Arrowhead Pharmaceuticals at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, South Korea, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113 (time frame: Baseline, Day 113). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.