Status:
COMPLETED
Renoprotective Effects of Telbivudine in Chronic Hepatitis B
Lead Sponsor:
The University of Hong Kong
Conditions:
Hepatitis B, Chronic
Chronic Kidney Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Renal impairment is common in patients with chronic hepatitis B infection. For those taking nucleotide analogues, renal toxicity of adefovir disoproxil (ADV) and tenofovir disoproxil fumarate (TDF) is...
Detailed Description
Background Both CHB and chronic kidney disease are major health issue affecting millions of persons worldwide. Based on a large European multicenter database, the Virgil-database, it is estimated tha...
Eligibility Criteria
Inclusion
- Age 18 - 70 years
- Documented HBsAg positivity for at least 6 months. Patients can be either HBeAg positive AND HBV DNA \< 9 log10 copies/mL or HBeAg negative AND HBV DNA \< 7 log10 copies/mL
- On combination therapy (lamivudine and tenofovir or lamivudine and adefovir) for at least 1 year
- Documented serum creatinine at least in 2 separate occasions in the last 1 year before recruitment
- MDRD eGFR 30-89ml/min at baseline
Exclusion
- Concomitant liver disease including chronic hepatitis C and/or D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis
- Significant alcohol intake or drug abuse
- Pregnant subjects
- Patients with co-existing significant chronic kidney disease (e.g.post renal transplantation etc.)
- Allergic to any of the medications involved in the study
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03778567
Start Date
August 1 2013
End Date
May 31 2018
Last Update
December 19 2018
Active Locations (1)
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1
Department of Medicine, The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong