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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02238860

Enrollment

100

Registered

2014-09-12

Start date

2014-09-30

Completion date

2016-09-30

Last updated

2014-09-12

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

Conditions

Cirrhosis Due to Hepatitis B

Keywords

Hepatitis B, cirrhosis, Entacavir, enofovir

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.

Interventions

DRUGEntacavir

Entacavir-0.5 mg ,OD,for

DRUGTenofovir

Tenofovir ,300 mg,OD,for 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Outcome	48 weeks	Death

Countries

Pakistan

Contacts

Primary ContactDr mohammad sadik Memon, Fcps gastro

Sadikmemon@gmail.com022-232593

Backup ContactMadiha Zaki, MSC gastro

Madiyaah@gmail.com022-232593

Outcome results

None listed

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