Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

NCT01693679 | Unknown Phase 4 DMC

• 1 other identifier: Telbivudine
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

HBV-related Liver Cirrhosis

Keywords

Tebivudine eGFR non-Tebivudine

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks

  No.

  May 2014

Secondary Outcomes (1)

• 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

  May 2014

Study Arms (1)

antiviral drug

EXPERIMENTAL

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

Interventions

Telbivudine, Lamivudine, Adefovir ,Enecavir DRUG

investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.

Also known as: no.

antiviral drug

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shao-quan Zhang: lead

MeSH Terms

Interventions

Telbivudine; Lamivudine

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 26, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Last Updated: September 26, 2012

Record last verified: 2012-09