Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

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

Study Overview

• Status: Unknown
• Conditions: HBV-related Liver Cirrhosis
• Intervention / Treatment: Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: antiviral drug; 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.	Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir; investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.; Other Names: no.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks	No.	May 2014

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	No.	May 2014

Collaborators and Investigators

• Sponsor: Shao-quan Zhang

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): April 1, 2014
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Estimate): September 26, 2012
• Last Update Submitted That Met QC Criteria: September 24, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Tebivudine eGFR non-Tebivudine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Lamivudine; Telbivudine; Adefovir
• Other Study ID Numbers: Telbivudine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No