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The effectiveness and safety of 0.5mg/d and 1mg/d entacavir for treatment of acute-on-chronic hepatitis B liver failure patients with high viral load

The effectiveness and safety of 0.5mg/d and 1mg/d entacavir for treatment of acute-on-chronic hepatitis B liver failure patients with high viral load——a open-label randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015921
Enrollment
Unknown
Registered
2018-04-29
Start date
2018-05-15
Completion date
Unknown
Last updated
2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV related acute-on-chronic liver failure

Interventions

ETV 1mg/d:ETV 1mg/d
ETV 0.5mg/d:ETV 0.5mg/d

Sponsors

Third Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 65 years old male and female; (2) History of positive serum HBsAg for over 6 months; (3) HBV DNA= 6log10 IU/ml; (4) eGFR=90 ml/min/1.73m^2; (5) Meet the ciriteria for ACLF of APASL consensus; (6) be able to provide a signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Patient who is ongoing NAs when hepatitis flare (that result in this ACLF) occurs; (2) Women who are pregnant, nursing, or plan to bear babies in the next two years; (3) Patient who have malignants during enrollment, such as liver cancer, lung cancer, etc.; (4) Patient who complicated with other severe diseases, such as severe heart or pulmonary diseases, hematopathy, autoimmune diseases; (5) Patient who are allergic to NAs, especially entecavir; (6) Patient who have drugs or alcohol abuse; (7) Patient who have severe hepatoencephalopathy (grade IV) or other conditions which unable patients deglutition of pills; (8) Patient who need long-term use immune-modulating medicine, such as glucocorticoid, biologics; (9) Patient who co-infected with HAV, HCV, HEV, or HIV, etc.; (10) Patient who complicated with other liver diseases, such as autoimmune liver diseases, Wilson diseases, alcoholic liver diseases, or non-alcoholic liver diseases; (11) Patients with other conditions making whom inappropriate to the trail.

Design outcomes

Primary

MeasureTime frame
survival at the third month;

Secondary

MeasureTime frame
survival at the 6th month;HBV DNA;

Countries

China

Contacts

Public ContactYuankai WU

The Department of infectious diseases, Third Affiliated Hospital, Sun Yat-sen University

wuyk2007@126.com+86 13760828467

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026