Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

NCT01693679 — Phase 4, Unknown, 120 participants, Shao-quan Zhang

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Registry	NCT01693679
Status	Unknown
Phase	Phase 4
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	120 (Estimated)
Sponsor	Shao-quan Zhang (Other)
Conditions	HBV-related Liver Cirrhosis
Interventions	Telbivudine, Lamivudine, Adefovir ,Enecavir (Drug)
Dates	start 2012-09-01, primary completion 2014-04-01 (estimated), first posted 2012-09-26, last updated 2012-09-26

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
antiviral drug	Experimental	Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir	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.

Telbivudine, Lamivudine, Adefovir ,Enecavir (Drug), also known as no.: investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.

+Outcome measures

Primary outcomes

Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks [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]: No.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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