Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Sun Yat-sen University.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Liver Diseases
Digestive System Diseases
Lamivudine
Adefovir
Telbivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 16, 2014