HBV-related Liver Cirrhosis Clinical Trial
Official title:
Telbivudine Renoprotective Effect in Patients With the HBV-related Liver Cirrhosis: a Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01693679 -
Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis
|
Phase 4 |