Entecavir
Drugantiviral therapy
Other names: entecavir dispersible tablets
NCT Number: NCT01938781
Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2/S3 (similar to metavir F2/F3, Ishak 2/3/4) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus pegylated interferon (peg-IFN) for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, thyroid function, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
302 Military Hospital Of China, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
antiviral therapy
Other names: entecavir dispersible tablets
antiviral and antifibrosis therapy
Other names: Pegasys
Time frame: 1.5 to 2 years
Fibrosis regression of 1 point by Ishak scoring system
Time frame: 1 year and 2 years
The HBVDNA undetectable rate after 1 year and 2-year treatment
Time frame: 1 year and 2 years
Fibroscan scores after 1 and 2-year treatment
Time frame: 1 year and 2 years
Life quality after 1 and 2-year treatment by SF-36 and EQ-5D questionaire
Time frame: 1 year and 2 years
Incidence of drug resistance after 1 and 2-year treatment
Beijing Friendship Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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