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

Cirrhosis Due to Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02238860
• Other study ID #: AIMS-hep B-123
• Status: Recruiting
• Phase: Phase 4
• First received: September 10, 2014
• Last updated: September 11, 2014
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2014
• Source: Asian Institute Of Medical Sciences
• Contact: Dr mohammad sadik Memon, Fcps gastro
• Phone: 022-232593
• Email: Sadikmemon[@]gmail.com
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis Due to Hepatitis B
• Hepatitis B
• Liver Cirrhosis

Intervention

Drug:
• Entacavir
Entacavir-0.5 mg ,OD,for
• Tenofovir
Tenofovir ,300 mg,OD,for 48 weeks

Locations

Country	Name	City	State
Pakistan	Asian Institute of medical Sciences	Hyderabad	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute Of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Outcome	Death	48 weeks	Yes
Primary	Safety and efficacy	EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.	48 weeks	Yes
Secondary	Safety	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.	48 weeks	Yes