ong-term Safety of Entecavir and Tenofovir in Patients with Chronic Hepatitis B virus infectio

Not Applicable

Recruiting

• Conditions: Diseases of the digestive system

• Registration Number: KCT0003487
• Lead Sponsor: Hanyang University Seoul Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Patients aged 18 or older with CHB
2. Patients with treatment-naïve chronic hepatitis B virus (CHB) infection between 2012 and 2015 in the applicable hospital
(including interferon-based treatment or oral antiviral agents within 3 months due to acute hepatitis B exacerbation)
3. Patients with antiviral treatment for 6 months or over

Exclusion Criteria

1. Patients with no initial treatment between 2012 and 2015 in the hospital
2. Patients who have taken antiviral agents in another hospital
3. Patients with chronic hepatitis C, HIV and coinfection
4. Patients with history of hepatocellular carcinoma
5. Patients diagnosed with malignant tumor(except hematologic malignancy) within 5 years prior to antiviral treatment
6. Patient with insufficient data

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eGFR

Secondary Outcome Measures

Name	Time	Method
Calcium, phosphorous and creatinine;HBV-DNA negativity rate;HBe-antigen seroconversion rate;Hepatocellular carcinoma incidence;Child-Pugh score or MELD (>=2 points)