Renoprotective Effects of Telbivudine in Chronic Hepatitis B

NCT03778567 | Completed Phase 4 DMC

• 1 other identifier: HKUCTR - 1639
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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 a significant concern in chronic hepatitis B (CHB) patients. Early observational clinical data suggested that telbivudine (LdT) might have renoprotective effects. In this prospective study, consecutive CHB patients on combined lamivudine (LAM)+ADV/TDF are switched to LdT+ADV/TDF at recruitment and are followed up for 24 months. Estimated glomerular filtration rate (eGFR) is calculated with the Modification of Diet in Renal Disease (MDRD) equation. The effects of LdT on cell viability and expression of kidney injury or apoptotic biomarkers are investigated in cultured renal tubular epithelial cell line HK-2.

Conditions

Hepatitis B, Chronic; Chronic Kidney Diseases

Keywords

chronic hepatitis B infection; telbivudine; chronic kidney disease; nucleotide analogue

Outcome Measures

Primary Outcomes (1)

• Renal function change

  Describe the change in renal function after 108 weeks of telbivudine switch

  108 weeks

Secondary Outcomes (2)

• Virologic suppression

  108 weeks

• Adverse events

  108 weeks

Study Arms (1)

lamivudine + nucleotide analogue

OTHER

At the time of recruitment (0 month, baseline), lamivudine is switched to telbivudine while adefovir or tenofovir disoproxil fumarate was continued

Drug: Telbivudine

Interventions

Telbivudine DRUG

CHB patients who are receiving adefovir or tenofovir disoproxil fumarate are recruited. At the time of recruitment (0 month, baseline), lamivudine is switched to telbivudine while adefovir or tenofovir disoproxil fumarate was continued. The patients are followed-up for 24 months.

Also known as: lamivudine is switched to telbivudine

lamivudine + nucleotide analogue

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Medicine, The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• Mak LY, Liu SH, Yap DY, Seto WK, Wong DK, Fung J, Chan TM, Lai CL, Yuen MF. In Vitro and In Vivo Renoprotective Effects of Telbivudine in Chronic Hepatitis B Patients Receiving Nucleotide Analogue. Dig Dis Sci. 2019 Dec;64(12):3630-3641. doi: 10.1007/s10620-019-05717-0. Epub 2019 Jul 6.

  PMID: 31280390 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic; Renal Insufficiency, Chronic

Interventions

Telbivudine

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Man-Fung Yuen, DSc, MD, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of Department

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: August 1, 2013
• Primary Completion: June 16, 2016
• Study Completion: May 31, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

HK (1)