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Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693679
Recruitment Status : Unknown
Verified September 2012 by Shao-quan Zhang, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : September 26, 2012
Last Update Posted : September 26, 2012
Information provided by (Responsible Party):
Shao-quan Zhang, Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
HBV-related Liver Cirrhosis Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2012
Estimated Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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 Name: no.

Primary Outcome Measures :
  1. Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks [ Time Frame: May 2014 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Shao-quan Zhang, Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University Identifier: NCT01693679     History of Changes
Other Study ID Numbers: Telbivudine
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012
Keywords provided by Shao-quan Zhang, Sun Yat-sen University:
Tebivudine eGFR non-Tebivudine
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Adefovir dipivoxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents