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

September 11, 2014 updated by: Mohammad sadik memon, Asian Institute Of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Hyderabad, Sindh, Pakistan, 71800
        • Recruiting
        • Asian Institute of Medical sciences
        • Contact:
        • Principal Investigator:
          • Dr sadik Memon, FCPS gastro
        • Sub-Investigator:
          • Dr Madiha Zaki, MSC gastro
        • Sub-Investigator:
          • Dr NANDLAL Serani, FCPS gastro
        • Sub-Investigator:
          • Dr Umar Soomro, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Entacavir
Entacavir 0.5 mg (OD) for 48 weeks
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
Active Comparator: Tenofovir
Tenofovir 300 mg ,OD for 48 weeks
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 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.
48 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome
Time Frame: 48 weeks
Death
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute Of Medical Sciences

Investigators

  • Principal Investigator: Mohammad sadik Memon, Fcps gastro, Aims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIMS-hep B-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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