A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asian Institute Of Medical Sciences
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• Age (18 years- 70 years)

• Hbv surface antigen positive > 6 months

• HbeAg (positive or negative both)

• Hbv DNA 10^3

• ALT ULN

• No evidence of HCC

• Platelets count > 30 thousands

• CTP score > 7

• Hepatic encephalopathy (grade 1 - 2 only)

• No prior Drug resistance

Exclusion Criteria:

• Age < 18 years

• HCC patients

• Prior drug resistance

• Current HE > 2

• Solid organ transplantation

• Inadequate hematological function

• Co infection with hepatitis C and HIV

• Autoimmune disorders

• Pregnancy and Breast feeding

• Other hepatic diseases

• Patients on immunosuppressant or chemotherapy agents