Hepatitis BPhase 2MONARCHNCT02577029
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)
A Phase 2 study testing ARC-520, entecavir and pegylated interferon alpha 2a in people with Hepatitis B and Hepatitis D, run by Arrowhead Pharmaceuticals at 33 sites in 8 countries.
Trial summary
Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, 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, Hepatitis D
- What is being tested?
- ARC-520, entecavir and pegylated interferon alpha 2a
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 33 sitesin 8 countries
- Study dates
- Dec 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
- Diagnosis of HBeAg negative or positive chronic HBV infection.
- Must be HBsAg (+) during screening.
- Must be treatment naïve: never on PEG IFN alpha 2a and/or ETV or TDF; and
- Have not used nucleoside/nucleotide analogs (NUCs) within the last 2 years prior to dosing on Day 1
- 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 severe infections within 4 weeks of screening
- Use within the last 14 days or anticipated requirement for anticoagulants, systemic 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, over-the-counter (OTC) and prescription pain medication or hormonal contraceptives
- History of poorly controlled autoimmune disease or any history of autoimmune hepatitis
- History of heterozygous or homozygous familial hypercholesterolemia.
Show all 22Show fewer
- Human immunodeficiency virus (HIV) infection
- Is sero-positive for Hepatitis C Virus (HCV), or has a history of delta virus hepatitis (except for cohort in which delta virus infection is acceptable)
- Has hypertension: blood pressure > 170/100 mmHg; well-controlled blood pressure on hypertensive medication allowed
- History of cardiac rhythm disturbances
- Family history of 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 major surgery within 1 month of screening
- Regular use of alcohol within 6 months prior to screening (ie, more than 14 units of alcohol per week)
- Use of recreational drugs such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year prior to the screening
- History of allergy to bee sting
- Clinically significant history of any alcoholic liver disease, cirrhosis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency
- Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction
- Clinically significant history or presence of poorly controlled/uncontrolled systemic disease
- Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk
- History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s)
Trial locations and contacts
33 sites in 8 countries.
33 sites in 8 countries
Australia9 sites
Research Site 9
Adelaide, South Australia, 5000
Research Site 3
Camperdown, New South Wales, 2050
Research Site 6
Clayton, Victoria, 3168
Research Site 8
Concord, New South Wales, 2139
Research Site 5
Darlinghurst, New South Wales, 2010
Research Site 4
Fitzroy, Victoria, 3065
Research Site 7
Nedlands, Washington, 6009
Research Site 2
Parkville, Victoria, 3052
Research Site 1
Westmead, New South Wales, 2145
South Korea6 sites
Research Site 17
Busan, 49241
Research Site 19
Busan
Research Site 16
Daegu, 41944
Research Site 18
Seoul, 3080
Research Site 15
Seoul, 6273
Research Site 20
Seoul
Thailand6 sites
Research Site 29
Bangkok, 10330
Research Site 30
Bangkok, 10400
Research Site 32
Bangkok, 10400
Research Site 33
Chiang Mai, 50200
Research Site 31
Khon Kaen, 40002
Research Site 34
Pathum Thani, 12120
Bulgaria4 sites
Research Site 13
Pleven, 5800
Research Site 10
Sofia, 1431
Research Site 11
Sofia, 1463
Research Site 12
Varna, 9020
New Zealand3 sites
Research Site 21
Auckland, 1010
Research Site 24
Dunedin, Otago-Southland
Research Site 23
Papatoetoe, Aukland, 2025
Taiwan3 sites
Research Site 26
Changhua, 500
Research Site 27
Douliu, Yunlin County, 640
Research Site 28
Kaohsiung City, 807
About this study
Official title: A Multicenter, Open-Label Study to Evaluate ARC-520 Administered Alone and in Combination With Other Therapeutics in Patients With Chronic Hepatitis B Virus (HBV) Infection (MONARCH)
Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be evaluated for safety and efficacy.
Read the detailed description
This is a multicenter, open-label study of ARC-520 based treatment regimens administered to patients with HBeAg positive or HBeAg negative immune active chronic Hepatitis B Virus (HBV) infection of various genotypes, or patients with Hepatitis D Virus (HDV). Eligible patients naive to previous treatment, and who have signed an Ethics Committee - approved informed consent, will be enrolled and will receive ARC-520 alone or ARC-520 plus additional treatments such as entecavir (ETV) or tenofovir (TDF) and/or pegylated interferon alpha 2a (PEG IFN) therapy. The study may initially involve up to a total of 96 eligible chronic HBV and HDV infected patients. Patients in all cohorts will receive a total of 13 doses of ARC-520 at 2mg/kg or 4 mg/kg. 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 ECGs, liver fibrosis testing, concomitant medication assessment, blood sample collection for hematology, coagulation, chemistry, exploratory Pharmacodynamic (PD) measures, urinalysis, HBV serology, cytokines, 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 96 weeks, from enrolment to last visit. Prior to enrolment there is a 60 day screening period. Addition of new cohorts and additional treatment regimens are anticipated for this study.
- Conditions
- Hepatitis B, Hepatitis D
- Being tested
- ARC-520, entecavir, pegylated interferon alpha 2a, tenofovir disoproxil, antihistamine
- Medical subject headings
- Hepatitis B, Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-520Drug
ARC-520 will be administered intravenously concomitantly with 0.9% normal saline using an infusion rate of 0.4 mL/min (24 mL/hour) for study treatment and 200 mL/hr for saline.
entecavirDrug
Also called Baraclude
0.5 mg once daily; oral
pegylated interferon alpha 2aBiological
Also called Peginterferon, Pegasys
180 mcg; subcutaneous injection once weekly
tenofovir disoproxilDrug
Also called Viread
300 mg once daily; oral
antihistamineDrug
All participants will be pre-treated with an oral antihistamine selected by the investigator from the list of approved antihistamines that is available in that country. Acceptable antihistamines are: diphenhydramine 50 mg p.o., chlorpheniramine 8 mg p.o., hydroxyzine 50 mg p.o., or cetirizine 10 mg p.o.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Treatment-naïve, hepatitis B "e" antigen (HBeAg)-positive participants with chronic hepatitis B (CHB) of any genotype administered ARC-520 (2 mg/kg intravenous [IV]) every 4 weeks for 48 weeks (13 doses). Receives: Drug: ARC-520; Drug: antihistamine |
| Cohort 2 | Experimental | Treatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered peginterferon (PEG IFN) alpha 2a for 48 weeks starting Day 87. Receives: Drug: ARC-520; Drug: entecavir; Biological: pegylated interferon alpha 2a; Drug: tenofovir disoproxil; Drug: antihistamine |
| Cohort 3 | Experimental | Treatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87. Receives: Drug: ARC-520; Drug: entecavir; Biological: pegylated interferon alpha 2a; Drug: tenofovir disoproxil; Drug: antihistamine |
| Cohort 4 | Experimental | Treatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87. Receives: Drug: ARC-520; Drug: entecavir; Biological: pegylated interferon alpha 2a; Drug: tenofovir disoproxil; Drug: antihistamine |
| Cohort 5 | Experimental | Treatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87. Receives: Drug: ARC-520; Drug: entecavir; Biological: pegylated interferon alpha 2a; Drug: tenofovir disoproxil; Drug: antihistamine |
| Cohort 6 | Experimental | Treatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87. Receives: Drug: ARC-520; Drug: entecavir; Biological: pegylated interferon alpha 2a; Drug: tenofovir disoproxil; Drug: antihistamine |
| Cohort 7 | Experimental | Treatment-naïve, HBeAg-negative or HBeAg-positive participants with hepatitis delta virus (HDV) administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15. Receives: Drug: ARC-520; Biological: pegylated interferon alpha 2a; Drug: antihistamine |
| Cohort 8 | Experimental | Treatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses). Receives: Drug: ARC-520; Drug: antihistamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline
The percentage of participants with chronic HBV achieving a 1-log reduction in HBsAg compared to baseline (mean of pre-dose values) at Week 60 after completion of 48 weeks of ARC-520 Injection.
Measured: Baseline, Week 60
Secondary outcomes (11)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment
The Principal Investigator (or medically qualified designee) will use clinical judgment to determine the relationship. An adverse event (AE) was considered "possibly related" when there is a reasonable possibility that the incident, experience, or outcome may have been caused by the product under investigation. An AE was considered "probably related" when there are facts, evidence, or arguments to suggest that the event is related to the product under investigation. Only AEs that occurred post-dose were considered treatment-emergent. Clinically significant abnormal laboratory findings or other abnormal assessments that are detected during the study or are present at baseline and significantly worsen following the start of the study will be reported as AEs.
Measured: From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
Percentage of Participants With HBsAg Loss (Based on Qualitative Assay) Over Time
The qualitative HBsAg assay gives a binary result, positive or negative.
Measured: Weeks 52, 60, 72 and 96
Percentage of Participants Achieving a 1-log Reduction in HBsAg and Achieving an HBsAg Level < 100 IU/L Over Time
Measured: Weeks 52, 60, 72 and 96
Time to HBsAg Loss
Measured: Baseline through Week 96
Time to Anti-HBs (Antibody to Hepatitis B Surface Antigen) Seroconversion
Measured: Baseline through Week 96
Percentage of Participants With Anti-HBs Seroconversion Over Time
Measured: Weeks 52, 60, 72 and 96
Percentage of Participants With HBeAg Loss and Anti-Hepatitis B e Antigen (Anti-HBe) Seroconversion (if HBeAg-Positive at Study Entry) Over Time
Measured: Weeks 52, 60, 72 and 96
Percentage of Participants With Resistance to ARC-520 Injection by Week 52
Resistance is defined as > 1.0 log IU/mL quantitative HBsAg (qHBsAg) increase from nadir, confirmed by repeat test.
Measured: Week 52
Percentage of Participants With Resistance to the Combination Therapy From Baseline to Week 60
Resistance is defined as > 1.0 log IU/mL increase in HBV DNA from nadir, confirmed by repeat test.
Measured: Baseline, Week 60
Percentage of Participants With HDV With Undetectable HDV Ribonucleic Acid (RNA) After 48 Weeks of Concomitant ARC-520 Injection and PEG IFN Alpha 2a Therapy Over Time (Cohort 7 Only)
Measured: Weeks 52, 60, 72 and 96
Log Change From Baseline in Quantitative HBV Deoxyribonucleic Acid (DNA) Serum Levels Over Time
Measured: Baseline, Weeks 52, 60, 72 and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startDec 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 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
- NCT02577029
- Sponsor's protocol ID
- Heparc-2008
- Other IDs
- 2015-005499-46, 2015
- Acronym
- MONARCH
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2015
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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, Open-Label Study to Evaluate ARC-520 Administered Alone and in Combination With Other Therapeutics in Patients With Chronic Hepatitis B Virus (HBV) Infection (MONARCH)
- ClinicalTrials.gov ID
- NCT02577029
- Acronym / sponsor ID
- MONARCH / Heparc-2008
- Conditions
- Hepatitis B, Hepatitis D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision to discontinue trial
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Posted 12 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 chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be evaluated for safety and efficacy.
Detailed description
This is a multicenter, open-label study of ARC-520 based treatment regimens administered to patients with HBeAg positive or HBeAg negative immune active chronic Hepatitis B Virus (HBV) infection of various genotypes, or patients with Hepatitis D Virus (HDV). Eligible patients naive to previous treatment, and who have signed an Ethics Committee - approved informed consent, will be enrolled and will receive ARC-520 alone or ARC-520 plus additional treatments such as entecavir (ETV) or tenofovir (TDF) and/or pegylated interferon alpha 2a (PEG IFN) therapy. The study may initially involve up to a total of 96 eligible chronic HBV and HDV infected patients. Patients in all cohorts will receive a total of 13 doses of ARC-520 at 2mg/kg or 4 mg/kg. 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 ECGs, liver fibrosis testing, concomitant medication assessment, blood sample collection for hematology, coagulation, chemistry, exploratory Pharmacodynamic (PD) measures, urinalysis, HBV serology, cytokines, 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 96 weeks, from enrolment to last visit. Prior to enrolment there is a 60 day screening period. Addition of new cohorts and additional treatment regimens are anticipated for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ARC-520, Drug: antihistamineTreatment-naïve, hepatitis B "e" antigen (HBeAg)-positive participants with chronic hepatitis B (CHB) of any genotype administered ARC-520 (2 mg/kg intravenous [IV]) every 4 weeks for 48 weeks (13 doses). |
| Cohort 2 | Experimental | Drug: ARC-520, Drug: entecavir, Biological: pegylated interferon alpha 2a, Drug: tenofovir disoproxil, Drug: antihistamineTreatment-naïve, HBeAg-positive, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered peginterferon (PEG IFN) alpha 2a for 48 weeks starting Day 87. |
| Cohort 3 | Experimental | Drug: ARC-520, Drug: entecavir, Biological: pegylated interferon alpha 2a, Drug: tenofovir disoproxil, Drug: antihistamineTreatment-naïve, HBeAg-negative, Genotype B participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87. |
| Cohort 4 | Experimental | Drug: ARC-520, Drug: entecavir, Biological: pegylated interferon alpha 2a, Drug: tenofovir disoproxil, Drug: antihistamineTreatment-naïve, HBeAg-positive, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87. |
| Cohort 5 | Experimental | Drug: ARC-520, Drug: entecavir, Biological: pegylated interferon alpha 2a, Drug: tenofovir disoproxil, Drug: antihistamineTreatment-naïve, HBeAg-negative, Genotype C participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87. |
| Cohort 6 | Experimental | Drug: ARC-520, Drug: entecavir, Biological: pegylated interferon alpha 2a, Drug: tenofovir disoproxil, Drug: antihistamineTreatment-naïve, HBeAg-negative, Genotype D participants with CHB administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) concomitantly with daily orally administered ETV or TDF for approximately 60 weeks starting Day 1 and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 87. |
| Cohort 7 | Experimental | Drug: ARC-520, Biological: pegylated interferon alpha 2a, Drug: antihistamineTreatment-naïve, HBeAg-negative or HBeAg-positive participants with hepatitis delta virus (HDV) administered ARC-520 (2 mg/kg increasing to 4 mg/kg or 4 mg/kg IV) every 4 weeks for 48 weeks (13 doses) and weekly subcutaneously administered PEG IFN alpha 2a for 48 weeks starting Day 15. |
| Cohort 8 | Experimental | Drug: ARC-520, Drug: antihistamineTreatment-naïve, HBeAg-positive participants with CHB of any genotype administered ARC-520 (4 mg/kg IV) every 4 weeks for 48 weeks (13 doses). |
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
- Diagnosis of HBeAg negative or positive chronic HBV infection.
- Must be HBsAg (+) during screening.
Key exclusion criteria (22 listed)
- Pregnant or lactating
- Acute signs of hepatitis/other severe infections within 4 weeks of screening
- Use within the last 14 days or anticipated requirement for anticoagulants, systemic 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, over-the-counter (OTC) and prescription pain medication or hormonal contraceptives
- History of poorly controlled autoimmune disease or any history of autoimmune hepatitis
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-520ARC-520 will be administered intravenously concomitantly with 0.9% normal saline using an infusion rate of 0.4 mL/min (24 mL/hour) for study treatment and 200 mL/hr for saline. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
| entecavirAlso: Baraclude0.5 mg once daily; oral | Drug | Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| pegylated interferon alpha 2aAlso: Peginterferon, Pegasys180 mcg; subcutaneous injection once weekly | Biological | Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| tenofovir disoproxilAlso: Viread300 mg once daily; oral | Drug | Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| antihistamineAll participants will be pre-treated with an oral antihistamine selected by the investigator from the list of approved antihistamines that is available in that country. Acceptable antihistamines are: diphenhydramine 50 mg p.o., chlorpheniramine 8 mg p.o., hydroxyzine 50 mg p.o., or cetirizine 10 mg p.o. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
Primary outcome
Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline
Time frame: Baseline, Week 60
The percentage of participants with chronic HBV achieving a 1-log reduction in HBsAg compared to baseline (mean of pre-dose values) at Week 60 after completion of 48 weeks of ARC-520 Injection.
11 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment
Time frame: From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up
Percentage of Participants With HBsAg Loss (Based on Qualitative Assay) Over Time
Time frame: Weeks 52, 60, 72 and 96
Percentage of Participants Achieving a 1-log Reduction in HBsAg and Achieving an HBsAg Level < 100 IU/L Over Time
Time frame: Weeks 52, 60, 72 and 96
Time to HBsAg Loss
Time frame: Baseline through Week 96
Time to Anti-HBs (Antibody to Hepatitis B Surface Antigen) Seroconversion
Time frame: Baseline through Week 96
Percentage of Participants With Anti-HBs Seroconversion Over Time
Time frame: Weeks 52, 60, 72 and 96
Percentage of Participants With HBeAg Loss and Anti-Hepatitis B e Antigen (Anti-HBe) Seroconversion (if HBeAg-Positive at Study Entry) Over Time
Time frame: Weeks 52, 60, 72 and 96
Percentage of Participants With Resistance to ARC-520 Injection by Week 52
Time frame: Week 52
Percentage of Participants With Resistance to the Combination Therapy From Baseline to Week 60
Time frame: Baseline, Week 60
Percentage of Participants With HDV With Undetectable HDV Ribonucleic Acid (RNA) After 48 Weeks of Concomitant ARC-520 Injection and PEG IFN Alpha 2a Therapy Over Time (Cohort 7 Only)
Time frame: Weeks 52, 60, 72 and 96
Log Change From Baseline in Quantitative HBV Deoxyribonucleic Acid (DNA) Serum Levels Over Time
Time frame: Baseline, Weeks 52, 60, 72 and 96
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.
33 sites in 8 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 pegylated interferon alpha 2a in people with Hepatitis B and Hepatitis D, run by Arrowhead Pharmaceuticals at 33 sites in 8 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 22 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 33 sites in Australia, South Korea, Thailand, Bulgaria, New Zealand and 3 more countries. 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. 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 12 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?
Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline (time frame: Baseline, Week 60). 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.