Status:
UNKNOWN
A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
Lead Sponsor:
Asian Institute Of Medical Sciences
Conditions:
Cirrhosis Due to Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 ...
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 mo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02238860
Start Date
September 1 2014
End Date
September 1 2016
Last Update
September 12 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asian Institute of medical Sciences
Hyderābād, Sindh, Pakistan, 71800