Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01693679

Enrollment

120

Registered

2012-09-26

Start date

2012-09-30

Completion date

Unknown

Last updated

2012-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV-related Liver Cirrhosis

Keywords

Tebivudine eGFR non-Tebivudine

Brief summary

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

Interventions

DRUGTelbivudine, Lamivudine, Adefovir ,Enecavir

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks	May 2014	No.

Secondary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026