| Medical History and Physical Examinaton |
Includes body weight, vital signs |
| Clinical Chemistry |
ALT, AST, total bilirubin, alkaline phosphatase, total protein, albumin, BUN, creatinine, uric acid, cholesterol, triglycerides, glucose. Calcium, phosphorus, sodium, chloride and potassium are analyzed at BL. Electrolytes should be monitored on the other visits whenever clinically indicated |
| Hematology |
Complete blood count (hematocrit, WBC, platelets),including, differential, prothrombine time |
| Immunology and Special Chemistry |
α1-antitrypsin*, HAV IgM Ab*, HBsAg*,HBsAb*, HCV Ab*, HDV Ab*, AMA*, ANA*, ASA*, HIV Ab*, HBeAg, alfa-fetoprotein* |
| Virology |
Quantitative HBV-DNA measured by PCR |
| Thyroid Function Tests* |
TSH, T3 or T4 |
| Urinalysis |
Dipstick with subsequent microscopic evaluation if positive for hemoglobin |
| Chest X-Ray* |
Only for patients with pre-existing pulmonary disease. [Not necessary if (1) a chest X-ray available to the investigator has been obtained within the past 12 months and (2) the patient’s pulmonary disease has been clinically stable] |
| Electrocardiogram* |
Only for men ≥40 years of age, women ≥50 years of age, and anyone else with a history of preexisting cardiac disease |
| Liver Imaging (Ultrasound, CT or MRI) |
Only for patients with cirrhosis or marked fibrosis on prior liver biopsy or raised AFP to exclude hepatic neoplasia |
| HCG Pregnancy Test |
For women of childbearing potential, a negative urine (or serum) HCG test needs to be documented within 24 hours prior to the first dose |
| Ocular examination |
All patients at screening should have a baseline eye examination conducted by the investigator or another physician/ophthalmologist (including fundoscopic examination). In patients identified as having mild to moderate retinopathy at screening, a thorough eye examination (including fundoscopic examination) by an ophthalmologist should be performed as part of the screening process to establish a baseline prior to randomization and treatment |
Note: Tests marked above with an asterisk (*) do not need to be repeated if patients do not receive study drug any more. |