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 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT00704106
Eligibility Criteria:
KEY INCLUSION CRITERIA:
* Age 18 years or older
* All genders and ethnicity
* Positive HBsAg
* HBeAg positive and negative
* Pretreatment HBV DNA of 10,000 copies/mL or higher (for purposes of this study, both copies and equivalent IU measurements will be recorded and analyzed)
* Patients who are switched to, or prescribed, entecavir after treatment with adefovir for at least 12 weeks by the providing physician.
* Patients with and without prior lamivudine exposure will be enrolled but enrollment of lamivudine experienced cases will be limited to no more than 30 patients total
KEY EXCLUSION CRITERIA:
* Patients who refused to consent to the study
* Patients younger than 18
* Vulnerable subjects such as pregnant women, prisoners, employees, patients with significant cognitive deficits.
* Patients with prior exposure to another nucleoside for more than 2 weeks. Those with prior exposure to lamivudine will be enrolled under conditions detailed above.
* HIV co-infection
* HCV co-infection
* HDV co-infection
* Recipients of solid organ transplantation
* Patients who receive high-dose steroid (60 mg/d or higher and for longer than 10 days)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00704106
Study Brief:
Protocol Section:
NCT00704106