Chronic Hepatitis BPhase 2NCT02349126
Study of ARC-520 in Patient With Chronic Hepatitis B Virus
A Phase 2 study testing ARC-520 Injection in people with Chronic Hepatitis B, run by Arrowhead Pharmaceuticals at 1 site in Australia.
Trial summary
Patients with chronic HBV infection will receive ARC-520 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 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ARC-520 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2015to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 65 years of age
- Written informed consent
- No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment
- No abnormal finding of clinical relevance
- Diagnosis of immune active chronic HBV infection
- > 6 months of continuous treatment with daily, oral entecavir or tenofovir
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 or a toll receptor agonist in last 12 months
- Use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants
- Use of dietary and/or herbal supplements that can interfere with liver metabolism
Show all 36Show fewer
- Use of any drugs known to induce or inhibit hepatic drug metabolism
- Use of prescription medication or over-the-counter products
- Depot injection/implant of any drug except birth control.
- Known diagnosis of diabetes mellitus.
- History of autoimmune disease
- Human immunodeficiency virus (HIV) infection
- Sero-positive for HCV, and/or history of delta virus hepatitis
- Hypertension: blood pressure > 150/100 mmHg
- History of cardiac rhythm disturbances
- Family history of congenital long QT syndrome/unexplained sudden cardiac death
- Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease
- History of malignancy, except adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, in situ cervical cancer
- Major surgery within 3 months of screening
- History of alcohol and/or drug abuse < 12 months from screening
- Regularly uses alcohol within past 6 months (ie, more than 14 units of alcohol per week)
- Evidence of acute inflammation, sepsis, or hemolysis
- Diagnosed with a significant psychiatric disorder
- Use of drugs of abuse
- History of allergy to bee venom
- Use of investigational agents/devices within 30 days
- Current participation in an investigational study
- Clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease
- History/presence of Gilbert's syndrome, conditions that interfere with absorption, distribution, metabolism, excretion of drugs
- Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction
- Clinically significant history/presence of uncontrolled systemic disease
- Donated blood (500 mL) within 7 days prior to study treatment administration
- History of fever within 2 weeks of screening
- Immunization/planned immunization with live attenuated vaccine except influenza vaccine
- Excessive exercise/physical activity within 7 days of screening/enrolment or during study
- History of coagulopathy or stroke within past 6 months, and/or concurrent anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.
Read the detailed description
This is a single-center, open-label study of ARC-520 in combination with entecavir or tenofovir administered to patients with immune active chronic HBV infection. An iterative trial design is anticipated with potential inclusion of additional cohorts with anticipated enrollment of up to 60 patients. Patients who have signed a Human Research Ethics Committee approved informed consent, and have met all of the protocol eligibility criteria will continue receiving daily oral entecavir (0.5-1.0 mg/day) or daily oral tenofovir (300 mg/day) and a single IV injection of ARC-520. If a serious adverse event (SAE) deemed possibly or probably related to study drug should occur at any point during the study, any further dosing will be put on hold pending a complete review of safety data by the sponsor and the Principal Investigator. 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, AEs, 12-lead ECGs, concomitant medication, blood sample collection for hematology, coagulation, chemistry, PK and exploratory PD measures, HBV virology. Patients will be monitored for a total of 12 weeks. 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- ARC-520 Injection
- Keywords
- Hepatitis B, HBV infection, Hepatitis B Surface Antigen
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-520 InjectionDrug
Also called ARC-520
ARC-520 Injection is a liver-targeted antiviral therapeutic designed to treat chronic hepatitis B virus (HBV) infection via an RNA interference (RNAi) mechanism.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | ARC-520 Injection Receives: Drug: ARC-520 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: To evaluate the depth and duration of HBsAg decline in response to a single dose of ARC 520 in combination with entecavir or tenofovir in patients with chronic HBV infection
Measured: Through Day 85 post-dosing
Secondary outcomes (3)
Safety:To determine the safety and tolerability of ARC 520 through monitoring of adverse events, vital signs, physical exam changes, blood sampling for hematology, coagulation and chemistry and 12-lead ECGs
Measured: Through Day 85 post-dosing
Pharmacokinetic parameters: Cmax, AUC0-24, AUClast, AUCinf, CL, V=CL/kel, kel, t1/2
Blood samples collected immediately prior to infusion and immediately prior to end of infusion, and 0.5,1,3,6,24,48 hrs post-infusion.
Measured: Post dosing on Days 1,2 & 3
Allergenicity:Evaluate Allergenicity of ARC-520 through Bee Venom Allergy Test (IgE)
Measured: Within 30 days prior to first dose and at Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: Company decision to pursue alternative clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02349126
- Sponsor's protocol ID
- Heparc-2005
- Status last verified
- Dec 2025
- First submitted
- 20 Jan 2015
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of ARC-520 in Patient With Chronic Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT02349126
- Acronym / sponsor ID
- Heparc-2005
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, HBV infection, Hepatitis B Surface Antigen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision to pursue alternative clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
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 ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.
Detailed description
This is a single-center, open-label study of ARC-520 in combination with entecavir or tenofovir administered to patients with immune active chronic HBV infection. An iterative trial design is anticipated with potential inclusion of additional cohorts with anticipated enrollment of up to 60 patients. Patients who have signed a Human Research Ethics Committee approved informed consent, and have met all of the protocol eligibility criteria will continue receiving daily oral entecavir (0.5-1.0 mg/day) or daily oral tenofovir (300 mg/day) and a single IV injection of ARC-520. If a serious adverse event (SAE) deemed possibly or probably related to study drug should occur at any point during the study, any further dosing will be put on hold pending a complete review of safety data by the sponsor and the Principal Investigator. 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, AEs, 12-lead ECGs, concomitant medication, blood sample collection for hematology, coagulation, chemistry, PK and exploratory PD measures, HBV virology. Patients will be monitored for a total of 12 weeks. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: ARC-520 InjectionARC-520 Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18 to 65 years of age
- Written informed consent
- No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment
- No abnormal finding of clinical relevance
- Diagnosis of immune active chronic HBV infection
Key exclusion criteria (36 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 or a toll receptor agonist in last 12 months
- Use of 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 InjectionAlso: ARC-520ARC-520 Injection is a liver-targeted antiviral therapeutic designed to treat chronic hepatitis B virus (HBV) infection via an RNA interference (RNAi) mechanism. | Drug | Treatment Group |
Primary outcome
Efficacy: To evaluate the depth and duration of HBsAg decline in response to a single dose of ARC 520 in combination with entecavir or tenofovir in patients with chronic HBV infection
Time frame: Through Day 85 post-dosing
3 secondary outcomes
Safety:To determine the safety and tolerability of ARC 520 through monitoring of adverse events, vital signs, physical exam changes, blood sampling for hematology, coagulation and chemistry and 12-lead ECGs
Time frame: Through Day 85 post-dosing
Pharmacokinetic parameters: Cmax, AUC0-24, AUClast, AUCinf, CL, V=CL/kel, kel, t1/2
Time frame: Post dosing on Days 1,2 & 3
Allergenicity:Evaluate Allergenicity of ARC-520 through Bee Venom Allergy Test (IgE)
Time frame: Within 30 days prior to first dose and at Day 29
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARC-520 Injection in people with Chronic Hepatitis B, run by Arrowhead Pharmaceuticals at 1 site in Australia.
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 6 inclusion and 36 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: withdrawn, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy: To evaluate the depth and duration of HBsAg decline in response to a single dose of ARC 520 in combination with entecavir or tenofovir in patients with chronic HBV infection (time frame: Through Day 85 post-dosing). 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 26 Dec 2025.