NCT01693679UnknownPhase 4
Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis
Shao-quan Zhang0 sites120 target enrollmentStarted: September 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks
Study Overview
Brief Summary
• To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver cirrhosis.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Telbivudine, Lamivudine, Adefovir ,Enecavir (Drug)
Outcomes
Primary Outcomes
Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks
Time Frame: May 2014
No.
Secondary Outcomes
- 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)
Investigators
Shao-quan Zhang
Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University
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