Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

HBV-related Liver Cirrhosis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01693679
• Other study ID #: Telbivudine
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 20, 2012
• Last updated: September 24, 2012
• Start date: September 2012

Study information

• Verified date: September 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Federal Institute for Drugs and Medicinal Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HBV-related Liver Cirrhosis
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shao-quan Zhang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks	No.	May 2014	Yes
Secondary	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	No.	May 2014	Yes