Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

• To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver cirrhosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shao-quan Zhang
• Treatments: Adefovir; Adefovir dipivoxil; Lamivudine; Telbivudine

Criteria

Inclusion Criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

• Aged between 18-75 years (inclusive).

• Male or female.

• Subjects with positive HBsAg for more than 6 months and anti-HBs negative regardless of HBeAg status , HBV DNA ≥2×103 IU/ml

• Subjects with HBV-related liver cirrhosis, including compensated cirrhosis and decompensated, but only Child-Pugh A or B.

• The ablility to understand and sign a written informed consent prior to any study related procedure and comply with the requirements of the study.

Exclusion Criteria:

• Subjects meeting any of the following criteria must not be enrolled in the study

• Subjects with non-HBV cirrhosis

• Co-infection with HAV/HCV/HDV/ HIV

• Subjects who take nucleosides within 6 months

• Kidney injury due to non-HBV factors

• Inability to comply with study requirements as determined by the study investigator

• Patients with very low GFR, who may need dialysis or renal transplantation