Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B… (NCT02577029) | Clinical Trial Compass
TerminatedPhase 2
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)
Stopped: Company decision to discontinue trial
Australia79 participantsStarted 2015-12
Plain-language summary
Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be evaluated for safety and efficacy.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
* Diagnosis of HBeAg negative or positive chronic HBV infection.
* Must be HBsAg (+) during screening.
* Must be treatment naïve: never on PEG IFN alpha 2a and/or ETV or TDF; and
* Have not used nucleoside/nucleotide analogs (NUCs) within the last 2 years prior to dosing on Day 1
* 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 severe infections within 4 weeks of screening
* Use within the last 14 days or anticipated requirement for anticoagulants, systemic 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, over-the-counter (OTC) and prescription pain medication or hormonal contraceptives
* History of poorly controlled autoimmune disease or any history of autoimmune hepatitis
* History of heterozygous or homozygous familial hypercholesterolemia.
* Human immunodeficiency virus (HIV) infection
* Is sero-positive for Hepatitis C Virus (HCV), or has a history of delta virus hepatitis (except for cohort in which del…
What they're measuring
1
Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline