Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

Phase 4

• Conditions: HBV-related Liver Cirrhosis
• Interventions: Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir

• Registration Number: NCT01693679
• Lead Sponsor: Shao-quan Zhang

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-24
• Last Update Submitted: 2012-09-24
• Study First Posted: 2012-09-26
• Last Update Posted: 2012-09-26
• Primary Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antiviral drug	Telbivudine, Lamivudine, Adefovir ,Enecavir	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks	May 2014	No.

Secondary Outcome Measures

Name	Time	Method
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	May 2014	No.