Telbivudine Renoprotective Effect in Patients With the HBV-related Liver Cirrhosis: a Randomized Controlled Trial

NCT01799486 | Unknown Phase 4 DMC

• 1 other identifier: Professor Bingliang Lin
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic hepatitis B virus (HBV) infection is a serious clinical problem because of its worldwide distribution and potential adverse outcome, including cirrhosis, which is a major cause of HBV related death. Studies show the use of nucleot(s)ide analogs treatment can alleviate, even reverse the progress of HBV-related cirrhosis. In cirrhosis stage, some potential factors, including endocrine disorder, renin, aldosterone, vasopressin increasing, hepatitis B virus related nephritis, hepatorenal syndrome, may cause renal damage. With the exposure of NAs, adverse reports of rhabdomyolysis, renal dysfunction, and lactic acidosis are increasing. So when choosing NAs, the potential renal function impairment should be considered. Recently, Gane, Xiaoxi Li have separately reported that Telbivudine can improve estimate of glomerular filtration rate (eGFR) of patients with chronic hepatitis B, while eGFR of patients with Lamivudine, adefovir and entecavir have a trend of decrease, which suggested Telbivudine may have renal protective effects. This effect on patients with HBV-related liver cirrhosis has not been studied, which is not clear now. This study is a randomized controlled study to prospectively observe Telbivudine's effect on renal function, which aims to provide evidence in antiviral treatment for the patients with cirrhosis.

Conditions

HBV-related Liver Cirrhosis

Keywords

Telbivudine; renoprotective efficacy; liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change of estimate of glomerular filtration rate (eGFR)* and Serum creatinine in week 4,12,18,24,48,72,96 in each Group.

  NO.

  up to 2years

Secondary Outcomes (1)

• Liver function change (ALB/GLB, ALT/AST, TB) in each Group

  up to 2 years

Other Outcomes (2)

• Percentage of subjects with ALT normalization rate at year 1and year 2 in each Group.

  up to 2 years

• The rate of complications (ascites, hepatorenal syndrome and so on)

  up to 2 years

Study Arms (3)

Telbivudine

EXPERIMENTAL

Telbivudine,600mg/d,oral,100patients,2 years.

Drug: Telbivudine

Adefovir

EXPERIMENTAL

Adefovir,10mg/d,oral,100 patients,2years.

Drug: Enecavir

Enecavir

EXPERIMENTAL

Enecavir,0.5mg/d,oral,100 patients,2 year

Drug: Adefovir

Interventions

Telbivudine DRUG

600 mg monotherapy supplied in film-coated tablets.

Also known as: No.

Telbivudine

Enecavir DRUG

0.5 mg monotherapy supplied in tablets.

Also known as: No.

Adefovir

Adefovir DRUG

10 mg monotherapy supplied in tablets.

Also known as: No.

Enecavir

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eGFR in baseline less than 90 ml.min-1.1.73m2
• 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. If eAg+, HBV DNA ≥2×104 IU/ml and \<2×108 IU/ml; If eAg-, HBV DNA ≥2×103 IU/ml and \<2×106 IU/ml.
• The ablility to understand and sign a written informed consent prior to any study related procedure and comply with the requirements of the study.

You may not qualify if:

• Subjects meeting any of the following criteria must not be enrolled in the study
• History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
• Patient is pregnant or breastfeeding.
• Subjects with non-HBV cirrhosis
• Co-infection with HAV/HCV/HDV/ HIV
• Patients who have previously been involved in a trial with telbivudine.
• Patient has received nucleoside or nucleotide drugs whether approved or investigational at any time.
• Patient has received IFN or other immunomodulatory treatment in the 6 months before Screening for this study.
• Patient has a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with previous findings suggestive of possible hepatocellular carcinoma (HCC), should have the disease ruled out prior to entrance into the study.
• Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years.
• Patient has a medical condition that requires frequent or prolonged use of systemic corticosteroids, although inhaled corticosteroids are allowed.
• Patient has a history of clinical and laboratory evidence of chronic renal insufficiency.
• Patient has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
• Patient has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.

Sponsors & Collaborators

• Lin Bingliang: lead
• Novartis: collaborator

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Telbivudine; adefovir

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lin Bingliang, PhD

  Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Third Affiliated Hospital of Sun Yat-sen University

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 26, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2015
• Last Updated: February 26, 2013

Record last verified: 2013-02