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:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT03038802
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* 18 years of age or older
* Current evidence of HBV chronic infection (with or without cirrhosis) as indicated by detection of HBsAg and/or Hepatitis B DNA (Subjects on current nucleoside therapy may have no detectable Hep B DNA)
* If child bearing age, using contraception (barrier method, IUD or oral contraception)
* Able to provide written informed consent
* Willing and able to comply with the protocol for the duration of the study.
Exclusion Criteria:
* Positive for antibody to hepatitis B core antigen (anti-HBc) IgM with negative results for the rest of the HBV markers, indicating acute infection,
* Positive for anti-delta virus, or anti-hepatitis C virus or HIV
* Childs Pugh Score for Cirrhosis Mortality of Child grade B or greater
* Liver transaminases greater than 5 times the upper limit of normal
* History of severe allergic reaction to hepatitis B vaccine.
* Pregnancy or female of child-bearing age not using effective method of contraception.
* Presence of any other organ-specific disease that in the opinion of the investigator may result in risk to the subject from involvement in the study
* Current alcohol or drug abuse that in the opinion of the investigator may result in non-compliance.
* Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03038802
Study Brief:
Protocol Section:
NCT03038802