UnknownPhase 4

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

Pakistan100 participantsStarted 2014-09

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety and efficacy

Timeframe: 48 weeks

Trial details

NCT IDNCT02238860

SponsorAsian Institute Of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

Contact for this trial

Dr mohammad sadik Memon, Fcps gastro

022-232593 Sadikmemon@gmail.com

View on ClinicalTrials.gov More Cirrhosis Due to Hepatitis B trials