A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic … (NCT02604212) | Clinical Trial Compass
TerminatedPhase 2
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection
Stopped: Company decision to discontinue trial
China, Germany32 participantsStarted 2015-11
Plain-language summary
Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
Who can participate
Age range18 Years – 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.
* 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 positive, immune active, chronic HBV infection.
* \> 2months 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 hepatiti…
What they're measuring
1
Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113