This trial is active, not recruiting.

Condition hbv-related liver cirrhosis
Treatment telbivudine, lamivudine, adefovir ,enecavir
Phase phase 4
Sponsor Shao-quan Zhang
Start date September 2012
End date April 2014
Trial size 120 participants
Trial identifier NCT01693679, Telbivudine


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Telbivudine team,Telbivudine,600mg/d,oral,60 patients. non-Tebivudine team,Lamivudine,100mg/d,oral,20 patients.Adefovir,10mg/d,oral,20 patients.Enecavir,0.5mg/d,oral,20 patients.
telbivudine, lamivudine, adefovir ,enecavir no.
investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.

Primary Outcomes

Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks
time frame: May 2014

Secondary Outcomes

Change from Baseline in ALT normalization rate,• The rate of complications,• Percentage of participants with HBeAg loss & HBeAg seroconversion and Percentage of subjects achieving HBV DNA<300copies/mL at96 weeks
time frame: May 2014

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.