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Long-term Safety of Entecavir and Tenofovir in Patients with Chronic Hepatitis B virus infection

Long-term Safety of Entecavir and Tenofovir in Patients with Treatment-naïve Chronic Hepatitis B Virus (CHB) Infection (SAINT study) in real life setting

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0003487
Enrollment
2000
Registered
2019-02-11
Start date
2016-11-01
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

None listed

Sponsors

Hanyang University Seoul Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
eGFR—

Secondary

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

Countries

Korea, Republic of

Contacts

Public ContactDae Won Jun

Hanyang University

gongori1004@gmail.com+82-2-2290-8338

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 28, 2026