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 @ 3:36 AM
Ignite Modification Date:
2025-12-25 @ 3:36 AM
NCT ID:
NCT00781105
Eligibility Criteria:
Inclusion Criteria:
* Male or female 16 to 65 year of age
* Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
* Willing and able to comply with the study drug regimen
* Written informed consent before any assessment
Exclusion Criteria:
* Patient has a history of/or clinical signs/symptoms of hepatic decompensation
* Patient has a history of HCC or findings suggestive of possible HCC
* Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
* History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
* Patient has received IFN or other immunomodulatory treatment with 12 months before screening
* Previous treatment history with NRTIs
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT00781105
Study Brief:
Protocol Section:
NCT00781105