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Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shao-quan Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01693679
First received: September 20, 2012
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks [ Time Frame: May 2014 ] [ Designated as safety issue: Yes ]
    No.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    No.


Estimated Enrollment: 120
Study Start Date: September 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Shao-quan Zhang, Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01693679     History of Changes
Other Study ID Numbers: Telbivudine
Study First Received: September 20, 2012
Last Updated: September 24, 2012
Health Authority: China: Federal Institute for Drugs and Medicinal Devices

Keywords provided by Sun Yat-sen University:
Tebivudine eGFR non-Tebivudine

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Adefovir
Adefovir dipivoxil
Lamivudine
Antiviral Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 21, 2013