Clareo Health | A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bukwang Pharmaceutical
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patient is 18 years and older.
2. Patient is documented to be HBsAg positive for \> 6 months and HBV DNA positive.
3. Patient is HBeAg positive or negative.
4. Patient has ALT levels ≥ 80 IU/L
5. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
You may not be if
1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Patients previously treated with interferon within the previous 3 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 is pregnant or breast-feeding.
6. Patient has a clinically relevant history of abuse of alcohol or drugs.
7. 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.
8. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
