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

Phase 4

• Conditions: Cirrhosis Due to Hepatitis B
• Interventions: Drug: Entacavir; Drug: Tenofovir

• Registration Number: NCT02238860
• Lead Sponsor: Asian Institute Of Medical Sciences

Brief 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.

Detailed Description

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 Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-11
• Last Update Submitted: 2014-09-11
• Study First Posted: 2014-09-12
• Last Update Posted: 2014-09-12
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir	Entacavir	Tenofovir 300 mg ,OD for 48 weeks
Entacavir	Entacavir	Entacavir 0.5 mg (OD) for 48 weeks
Tenofovir	Tenofovir	Tenofovir 300 mg ,OD for 48 weeks
Entacavir	Tenofovir	Entacavir 0.5 mg (OD) for 48 weeks

Primary Outcome Measures

Name	Time	Method
Safety and efficacy	48 weeks	EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.

Secondary Outcome Measures

Name	Time	Method
Safety	48 weeks	SAFETY ENDPOINTS: SAFETY ANALYSIS INCLUDED CUMALATIVE RATES ON TREATMENT ADVERSE EVENTS, SEREIOUS ADVERSE EFFECTS DISCONTINUATION DUE TO SIDE EFFECTS,DEATH,HCC,RENAL IMPAIRMENT , HEPATIC FLARE AND DEVELOPMENT OF DRUG RESISTANCE.

Trial Locations

Locations (1)

Asian Institute of medical Sciences; 🇵🇰 Hyderabad, Sindh, Pakistan