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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT00558818
Eligibility Criteria:
Inclusion Criteria
* Patient with DNA levels \>=1 x 10\^5 copies/mL within 30 days of baseline.
* Patient is documented to be HBsAg positive for \> 6 months.
* Patient has ALT levels \>=80 IU/L
* Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.
Exclusion Criteria.
* Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
* Patients previously treated with interferon within the previous 6 months.
* Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
* Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
* Patient is coinfected with HCV, HDV or HIV.
* Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
* Patient is pregnant or breast-feeding.
* Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
* Patient has a clinically relevant history of abuse of alcohol or drugs.
* Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
* Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00558818
Study Brief:
Protocol Section:
NCT00558818