Hepatitis b drug trial pulled before it started
NCT ID NCT02349126
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study was designed to test ARC-520, an experimental RNAi drug, in people with chronic hepatitis B who were already taking standard antiviral medications. The goal was to see if adding ARC-520 could lower hepatitis B surface antigen levels more effectively. However, the trial was withdrawn before enrolling any participants, so no results are available.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
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Start date
-
Feb 2015
- Expected to finish
-
Mar 2016
An estimate. End dates often move.
- Lead sponsor
-
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 65 years
- Sex
-
Anyone
- Healthy volunteers
-
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 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 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 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 * 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
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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
-
Research Site 1
Melbourne, Victoria, 3004, Australia
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