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Chronic Hepatitis BPhase 2NCT02452528

Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus

A Phase 2 study testing ARC-520, Entecavir and Tenofovir in people with Chronic Hepatitis B, run by Arrowhead Pharmaceuticals at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Participants with chronic HBV infection will receive multiple doses of 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 75 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
ARC-520, Entecavir and Tenofovir
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
4 sitesUnited States
Study dates
Aug 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
  • Body mass index (BMI) between 17.5 and 30.0 kg/m2
  • No clinically significant abnormalities at screening/pre-dose 12-lead ECG assessment
  • No abnormal finding of clinical relevance
  • Diagnosis of HBeAg positive, immune active, chronic HBV infection
  • > 2 months of continuous treatment with daily oral entecavir or tenofovir
  • Must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive)

Who cannot join

  • Pregnant or lactating
  • Acute signs of hepatitis/other infection within 4 weeks of screening
  • Hepatic transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) > 3 times the upper limits of normal
  • Liver Elastography (i.e. FibroScan®) score > 9
  • Antiviral therapy other than entecavir or tenofovir within 3 months of screening
  • Prior treatment with interferon in the last 3 years
Show all 38Show fewer
  • Use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants within 6 months of screening
  • Use within 7 days prior to screening of dietary and/or herbal supplements that can interfere with liver metabolism
  • Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days of study drug administration
  • Use of prescription medication within 14 days prior to study drug administration
  • Depot injection/implant of any drug except birth control within 3 months prior to study drug administration
  • Known diagnosis of diabetes mellitus
  • History of autoimmune disease
  • Human immunodeficiency virus (HIV) infection
  • Sero-positive for Hepatitis C Virus (HCV), and/or a history of delta virus hepatitis
  • Hypertension; blood pressure > 150/100 mmHg
  • 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, in situ cervical cancer
  • Major surgery within 3 months of screening
  • History of alcohol and/or drug abuse < 12 months from screening
  • Regular use of alcohol within 6 months (ie, more than 14 units of alcohol per week)
  • Evidence of systemic acute inflammation, sepsis, or hemolysis
  • Diagnosed with a significant psychiatric disorder
  • Use of drugs of abuse
  • History of allergy to bee venom
  • Positive reaction to the bee venom allergy immunoglobulin E (IgE) test
  • Use of investigational agents or devices within 30 days
  • Clinically significant inherited or acquired gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease
  • Presence of cholangitis, cholecystitis, cholestasis, or duct obstruction
  • Clinically significant history or presence of uncontrolled systemic disease
  • Donated or had a loss of whole blood of 50 milliliters (mL) to 499 mL within 30 days or more than 499 mL between 31 and 56 days prior to study treatment
  • History of fever within 2 weeks of screening
  • Immunization/planned immunization with live attenuated vaccine except influenza vaccine
  • Presence of any medical or psychiatric condition or social situation that impacts compliance or results in additional safety risk
  • Excessive exercise/physical activity within 7 days of screening/enrolment or during study
  • History of coagulopathy/stroke within past 6 months, and/or concurrent anticoagulant medication(s)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Research Site 2

    Miami, Florida, 33136

  • Research Site 4

    New York, New York, 10029

  • Research Site 6

    San Antonio, Texas, 78215

  • Research Site 1

    San Francisco, California, 94118

Other trials in United States

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

Participants with chronic HBV infection will receive multiple doses of ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.

Being tested
ARC-520, Placebo, Entecavir, Tenofovir, diphenhydramine
Keywords
Hepatitis B Virus, Chronic Hepatitis B, HBV
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-520Drug

  • PlaceboDrug

  • EntecavirDrug

    Also called Baraclude

    0.5 or 1.0 mg/day orally

  • TenofovirDrug

    Also called Viread

    300 mg/day orally

  • diphenhydramineDrug

    50 mg orally as pretreatment antihistamine

Study groups in NCT02452528
Study groupRoleWhat they receive
ARC-520ExperimentalIntravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study. Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug.
Receives: Drug: ARC-520; Drug: Entecavir; Drug: Tenofovir; Drug: diphenhydramine
PlaceboPlacebo comparatorIntravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study. Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo.
Receives: Drug: Placebo; Drug: Entecavir; Drug: Tenofovir; Drug: diphenhydramine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85

    Measured: Baseline, Day 85

Secondary outcomes (13)

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with treatment. An SAE was defined as 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; or is a medically important event or reaction. An AE was classified as a TEAE if the AE was not present prior to the first study medication administration and started at or after the time of initiation of administration of study medication, or if the AE presented prior to initiation of administration of study medication, continued and increased in intensity after administration of study medication.

    Measured: From time of informed consent through Day 147 ± 3 days

  2. 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 Days 1 and 57

  3. 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 Days 1 and 57

  4. 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 Days 1 and 57

  5. Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)

    Measured: Through 48 hours post-dosing on Days 1 and 57

  6. Pharmacokinetics of ARC-520: Apparent Clearance (CL)

    Measured: Through 48 hours post-dosing on Days 1 and 57

  7. Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)

    Measured: Through 48 hours post-dosing on Days 1 and 57

  8. Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)

    Measured: Through 48 hours post-dosing on Days 1 and 57

  9. Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)

    Measured: Through 48 hours post-dosing on Days 1 and 57

  10. Pharmacokinetics of Entecavir or Tenofovir: AUC0-24

    Measured: Through 24 hours post-dosing on Days 1 and 57

  11. Pharmacokinetics of Entecavir or Tenofovir: AUClast

    Measured: Through 24 hours post-dosing on Days 1 and 57

  12. Pharmacokinetics of Entecavir or Tenofovir: Cmax

    Measured: Through 24 hours post-dosing on Days 1 and 57

  13. Pharmacokinetics of Entecavir or Tenofovir: Time of Cmax (Tmax)

    Measured: Through 24 hours post-dosing on Days 1 and 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

Why it stopped: Company decision to discontinue trial

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02452528
Sponsor's protocol ID
Heparc-2004
Status last verified
Oct 2025
First submitted
15 May 2015
Last updated
3 Nov 2025
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARC-520, Entecavir and Tenofovir in people with Chronic Hepatitis B, run by Arrowhead Pharmaceuticals at 4 sites in United States.

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 38 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 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 1 Nov 2017). 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 85 (time frame: Baseline, Day 85). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02452528.

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 3 Nov 2025.

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