A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
NCT ID: NCT02238860
Last Updated: 2014-09-12
Study Results
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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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2014-09-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Entacavir
Entacavir 0.5 mg (OD) for 48 weeks
Entacavir
Entacavir-0.5 mg ,OD,for
Tenofovir
Tenofovir ,300 mg,OD,for 48 weeks
Tenofovir
Tenofovir 300 mg ,OD for 48 weeks
Entacavir
Entacavir-0.5 mg ,OD,for
Tenofovir
Tenofovir ,300 mg,OD,for 48 weeks
Interventions
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Entacavir
Entacavir-0.5 mg ,OD,for
Tenofovir
Tenofovir ,300 mg,OD,for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Asian Institute Of Medical Sciences
OTHER
Responsible Party
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Mohammad sadik memon
Professor of gastroenterology
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AIMS-hep B-123
Identifier Type: -
Identifier Source: org_study_id
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