Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

Shao-quan Zhang

Status and phase: Unknown; Phase 4

Conditions: HBV-related Liver Cirrhosis

Treatments: Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir

Study type: Interventional

Funder types: Other

Identifiers

NCT01693679

Telbivudine

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 1 patient group

antiviral drug

Experimental group

Description:

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.

Treatment:

Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir