Trial | NCT02238860  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.
Study Started
Sep 30
2014
Primary Completion
Sep 30
2016
Anticipated
Study Completion
Sep 30
2016
Anticipated
Last Update
Sep 12
2014
Estimate

Drug Entacavir

Entacavir-0.5 mg ,OD,for

  • Other names: ETV

Drug Tenofovir

Tenofovir ,300 mg,OD,for 48 weeks

  • Other names: TDF or PMPA

Entacavir Active Comparator

Entacavir 0.5 mg (OD) for 48 weeks

Tenofovir Active Comparator

Tenofovir 300 mg ,OD for 48 weeks

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
No Results Posted