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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT01264133
Eligibility Criteria:
Inclusion Criteria:
1. Patient is 18 years and older.
2. Patient is documented to be HBsAg positive for \> 6 months.
3. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
4. Patient has ALT levels \>=80 IU/L
5. Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis \<= 6)
6. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria:
1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
3. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
6. Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
7. Patient with previous liver transplantation
8. Patient is pregnant or breast-feeding.
9. Patient has a clinically relevant history of abuse of alcohol or drugs.
10. 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.
11. 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
Study:
NCT01264133
Study Brief:
Protocol Section:
NCT01264133