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:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-24 @ 9:35 PM
NCT ID:
NCT01217632
Eligibility Criteria:
Inclusion Criteria
* Signed informed consent
* Age of 18 to 75 years, inclusive
* HBsAg positive for ≥24 weeks prior to screening
* Liver fibrosis, confirmed by biopsy and histology
* Willing to use contraception
Exclusion Criteria:
* Female subjects who are pregnant or nursing
* Prior antiviral therapy, with the exception of interferon therapy \>6 months prior to Day 1
* Severe heart failure
* Present hepatocellular carcinoma and history of other cancers
* Severe anemia
* Advanced kidney disease
* Immunosuppressive therapy within 24 weeks prior to screening
* Alcohol or drug abuse within the 12 months prior to screening
* Trauma or surgical procedures requiring hospitalization within 8 weeks prior to Day 1
* Planned elective surgery during the study including 9 weeks following the final dose of study drug
* History of allergy against nucleoside analogs or human, humanized, chimeric, or murine monoclonal antibodies
* Inability to cooperate with study personnel or a history of noncompliance to the medical regimen (i.e., subjects who would be expected to comply poorly with the treatment)
* Clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study
* Morbid obesity (body mass index \[BMI\] \>40)
* Inadequate IV access
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01217632
Study Brief:
Protocol Section:
NCT01217632