Telbivudine Renoprotective Effect in Patients With the HBV-related Liver Cirrhosis: a Randomized Controlled Trial

Exclusion Criteria

• •Subjects meeting any of the following criteria must not be enrolled in the study
• •History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
• •Patient is pregnant or breastfeeding.
• •Subjects with non-HBV cirrhosis
• •Co-infection with HAV/HCV/HDV/ HIV
• •Patients who have previously been involved in a trial with telbivudine.
• •Patient has received nucleoside or nucleotide drugs whether approved or investigational at any time.
• •Patient has received IFN or other immunomodulatory treatment in the 6 months before Screening for this study.
• •Patient has a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with previous findings suggestive of possible hepatocellular carcinoma (HCC), should have the disease ruled out prior to entrance into the study.
• •History of any other acute or chronic medical condition that in the opinion of the investigator would make the patient unsuitable for inclusion into the study.
• •Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years.
• •Patient has a medical condition that requires frequent or prolonged use of systemic corticosteroids, although inhaled corticosteroids are allowed.
• •Patient has a history of clinical and laboratory evidence of chronic renal insufficiency.
• •Patient has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
• •Patient has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
• •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
• •Patient has a history of myopathy, myositis, or persistent muscle weakness.
• •Kidney impairment due to non-HBV factors
• •Inability to comply with study requirements as determined by the study investigator
• •Patients with eGFR≤15 ml.min-1.1.73m2, who may need dialysis or renal transplantation