Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepati⦠(NCT02452528) | Clinical Trial Compass
TerminatedPhase 2
Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus
Stopped: Company decision to discontinue trial
United States4 participantsStarted 2015-08
Plain-language 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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. FibroScanĀ®) score \> 9
* Antiviral therapy other than entecavir or tenofovir within 3 months of screening
* Prior treatment with interferon in the last 3 years
* 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 priorā¦
What they're measuring
1
Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85