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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT01198860
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria:
* Males and females ≥ 18 years of age with chronic and acute hepatitis B.
* Hepatitis B surface antigen (HBsAg)(+) for a minimum of 6 months prior to entry.
* Hepatitis B envelope antigen (HBeAg)(+) or (-) at baseline.
* Patients having treated or untreated
* Patients with compensated liver function (Child-Pugh score ≤ 6).
* Informed writted consent.
Exclusion Criteria:
* Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. or cytokine-based therapies with possible activity in hepatitis B disease within 6 months prior to study screening.
* Organ or bone marrow transplant recipients.
* Evidence of active liver disease to operate.
* Received immunoglobulins, interferon or other immune e to other causes (e.g., Wilson's disease, hemochromatosis, autoimmune hepatitis, hepatitis C, hepatitis D or HIV.)
* Patients taking parenteral (intravenous or intramuscular or subcutaneous) or oral steroids, immuno-suppressant therapies or chemotherapeutic agents within 2 months of study screening or expected to receive these agents during the course of the study.
* Clinically relevant alcohol or drug use or history of alcohol or drug use considered by the investigator to be sufficient to hinder compliance with treatment, follow up procedures or evaluation of adverse events.
* Hepatocellular carcinoma.
* Serious concurrent medical illness other than hepatitis B.
* History of hypersensitivity to nucleoside analogues.
* Women of childbearing potential not practising adequate contraception.
* Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01198860
Study Brief:
Protocol Section:
NCT01198860