A Randomized Trial to Compare Antiviral Efficacy and Safety in the Fasted state versus the Fed state in Chronic Hepatitis B patients with Entecavir treatment

A Randomized, Multi-center, Open-label, Investigator Initiated Trial to Compare Antiviral Efficacy and Safety in the Fasted state versus the Fed state in Chronic Hepatitis B patients with Entecavir treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003031

Enrollment

Registered

2018-07-26

Start date

2015-08-25

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Fed group: entecavir (Entecavir®

Bukwang Pharmaceutical Co.) 0.5mg qd within 30 min after meals, for 48 weeks Fasted group: entecavir (Entecavir®

Bukwang Pharmaceutical Co.) 0.5mg qd without meals (&gt

2 hour before or after meals)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects with chronic hepatitis B who are currently taking entecavir for =48 weeks 2. Subjects aged 19–75 years 3. Subjects with HBV DNA <20 IU/mL at screening 4. Subjects with HBeAg-Positive or HBeAg-negative diagnosed at the screening visit

Exclusion criteria

Exclusion criteria: 1. Subjects with decompensated liver disease (total bilirubin of greater than 2 times the ULN, albumin less than 3 g/dL, prothrombin time longer than 3 seconds of normal value, ascites or jaundice, history of variceal bleeding, hepatic encephalopathy) or hepatocellular carcinoma 2. Treatment-experienced subjects (those who previously received treatment with any oral antiviral agent except entecavir) or subjects with lamivudine resistance. 3. Currently receiving therapy with immunomodulators, cytotoxic chemotehrapy or corticosteroids 4. Subjects co-infected with hepatitis C, hepatitis D, or HIV. 5. Received solid organ or bone marrow transplant 6. Women who are pregnant or breastfeeding 7. Less than 60ml/min of creatinine clearance diagnosed at the screening visit 8. Subjects with hemoglobin less than 8 g/dL 9. Subjects with neutrophil counts less than 1,000/uL 10. Subjects with ALT greater than ten times the ULN 11. Subjects who participated in other clinical trials within three months before enrollment in this trial

Design outcomes

Primary

Measure	Time frame
Proportion of participants with serum HBV DNA < 20 IU/mL	—

Secondary

Measure	Time frame
Proportion of participants with serum HBV DNA < 20 IU/mL;Proportion of participants with serological response: seroconversion to anti-HBe in HBeAg-positive participants;Proportion of participants with normal ALT;Change from baseline in HBV DNA levels;Proportion of participants with virological breakthrough;Safety profiles	—

Countries

Korea, Republic of

Contacts

Public ContactEun Ju Cho

Seoul National University Hospital

creatioex@gmail.com+82-2-2072-2228

Outcome results