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

Primary Purpose

Cirrhosis Due to Hepatitis B

Status
Unknown status
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Entacavir
Tenofovir
Sponsored by
Asian Institute Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis Due to Hepatitis B focused on measuring Hepatitis B, cirrhosis, Entacavir, enofovir

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asian Institute of medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Entacavir

Tenofovir

Arm Description

Entacavir 0.5 mg (OD) for 48 weeks

Tenofovir 300 mg ,OD for 48 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 10, 2014
Last Updated
September 11, 2014
Sponsor
Asian Institute Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02238860
Brief Title
A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
Official Title
A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute Of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis Due to Hepatitis B
Keywords
Hepatitis B, cirrhosis, Entacavir, enofovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Entacavir
Arm Type
Active Comparator
Arm Description
Entacavir 0.5 mg (OD) for 48 weeks
Arm Title
Tenofovir
Arm Type
Active Comparator
Arm Description
Tenofovir 300 mg ,OD for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Entacavir
Other Intervention Name(s)
ETV
Intervention Description
Entacavir-0.5 mg ,OD,for
Intervention Type
Drug
Intervention Name(s)
Tenofovir
Other Intervention Name(s)
TDF or PMPA
Intervention Description
Tenofovir ,300 mg,OD,for 48 weeks
Primary Outcome Measure Information:
Title
Safety and efficacy
Description
EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
48 weeks
Other Pre-specified Outcome Measures:
Title
Outcome
Description
Death
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr mohammad sadik Memon, Fcps gastro
Phone
022-232593
Email
Sadikmemon@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Madiha Zaki, MSC gastro
Phone
022-232593
Email
Madiyaah@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad sadik Memon, Fcps gastro
Organizational Affiliation
AIMS Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asian Institute of medical Sciences
City
Hyderabad
State/Province
Sindh
ZIP/Postal Code
71800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr mohammad sadik Memon, FCPS gastro
Phone
022-232593
Email
Sadikmemon@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr sadik Memon, FCPS gastro
First Name & Middle Initial & Last Name & Degree
Dr Madiha Zaki, MSC gastro
First Name & Middle Initial & Last Name & Degree
Dr NANDLAL Serani, FCPS gastro
First Name & Middle Initial & Last Name & Degree
Dr Umar Soomro, MBBS

12. IPD Sharing Statement

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

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