Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT02738008
Eligibility Criteria:
Inclusion Criteria:
* Patient showed a ½ log or greater reduction in serum HBsAg levels from baseline to Day 71 ± 3 days or Day 99 ± 3 days in the primary Heparc-2002 or Heparc-2003 study.
* Able to have first dose within 2 months of day 113 end-of-study visit in the primary Heparc-2002 or Heparc-2003 study.
* Able to provide written informed consent prior to the performance of any study specific procedures.
* Have no abnormalities in 12-lead ECG assessment that, in the opinion of the investigator, may compromise patient safety
* Willing and able to comply with all study assessments and adhere to the protocol schedule.
* Have no new abnormal finding of clinical relevance at the screening evaluation.
* Using 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners) during the study and for 3 months following the last dose of (ARC 520).
Exclusion Criteria:
* Pregnant or lactating.
* Acute signs of hepatitis/other infection within 4 weeks of screening and/or at the screening examination.
* Use of prescription medication (including anticoagulants) within 14 days prior to administration of ARC-520.
* Has had major surgery within 3 months of screening.
* Has evidence of severe systemic acute inflammation, sepsis, or hemolysis.
* Diagnosed with a significant psychiatric disorder that would prevent participation in the study.
* Unable or unwilling to return for all scheduled study visits.
* Has any other condition that, in the opinion of the investigator, would render the patient unsuitable for enrollment, or could interfere with his/her participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02738008
Study Brief:
Protocol Section:
NCT02738008