Experimental hepatitis b drug shows promise in early trial
NCT ID NCT02604199
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested an experimental drug called ARC-520 in 58 people with chronic hepatitis B who were already taking standard antivirals. The goal was to see if ARC-520 could further lower hepatitis B surface antigen levels, a marker of the virus. The study was terminated early, so final results are not available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ARC-520 (an experimental RNA interference drug)
- What this could lead to
- If successful, ARC-520 could help control hepatitis B more effectively by reducing viral proteins, potentially lowering the risk of liver damage.
- What could go wrong
- This was an early Phase 2 trial that was terminated, so results are limited. The drug may not work as hoped, and side effects are possible. Patients still need lifelong antiviral medication.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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58 people
The number who actually took part.
- Started
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Sep 2015
- Finished
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Jan 2017
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 negative, immune active, chronic HBV infection * \> 2 months 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) Exclusion Criteria: * 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. * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site 1
Hong Kong, 999077, China
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Research Site 10
Leipzig, 04103, Germany
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Research Site 11
Frankfurt, 60590, Germany
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Research Site 12
Yangsan-si Gyeongnam, 626-770, South Korea
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Research Site 13
Busan, 602-739, South Korea
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Research Site 14
Seoul, 110-744, South Korea
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Research Site 15
Incheon, 405-760, South Korea
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Research Site 16
Seoul, 120-752, South Korea
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Research Site 2
Hong Kong, China
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Research Site 3
Tübingen, 72076, Germany
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Research Site 4
Leipzig, 4103, Germany
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Research Site 5
München, 81377, Germany
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Research Site 6
Ulm, 89081, Germany
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Research Site 7
Würzburg, 97080, Germany
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Research Site 8
Hanover, 30625, Germany
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Research Site 9
Hamburg, 20099, Germany
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