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

NCT ID: NCT02238860

Last Updated: 2014-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Cirrhosis Due to Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Entacavir

Entacavir 0.5 mg (OD) for 48 weeks

Group Type ACTIVE_COMPARATOR

Entacavir

Intervention Type DRUG

Entacavir-0.5 mg ,OD,for

Tenofovir

Intervention Type DRUG

Tenofovir ,300 mg,OD,for 48 weeks

Tenofovir

Tenofovir 300 mg ,OD for 48 weeks

Group Type ACTIVE_COMPARATOR

Entacavir

Intervention Type DRUG

Entacavir-0.5 mg ,OD,for

Tenofovir

Intervention Type DRUG

Tenofovir ,300 mg,OD,for 48 weeks

Interventions

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Entacavir

Entacavir-0.5 mg ,OD,for

Intervention Type DRUG

Tenofovir

Tenofovir ,300 mg,OD,for 48 weeks

Intervention Type DRUG

Other Intervention Names

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ETV TDF or PMPA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asian Institute Of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mohammad sadik memon

Professor of gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad sadik Memon, Fcps gastro

Role: PRINCIPAL_INVESTIGATOR

AIMS Institute

Locations

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Asian Institute of medical Sciences

Hyderābād, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Dr mohammad sadik Memon, Fcps gastro

Role: CONTACT

022-232593

Madiha Zaki, MSC gastro

Role: CONTACT

022-232593

Facility Contacts

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Dr mohammad sadik Memon, FCPS gastro

Role: primary

022-232593

Other Identifiers

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AIMS-hep B-123

Identifier Type: -

Identifier Source: org_study_id

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