TDF and Entekavir - Hepatitis B Reactivation

Hepatitis B Reactivation Clinical Trial

Official title:

Efficacy of TDF and Entekavir Prophylaxis at Hepatitis B Reactivation: Multi Center Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049602
• Other study ID #: IMMUNHEP
• Status: Recruiting
• Start date: January 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Viral Hepatitis Society
• Contact: Fehmi Tabak, Prof
• Phone: +905322763788
• Email: fehmitabak[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a non-interventional retrospective multi-center study for the patients received Entekavir or TDF for Hepatitis B prophylaxis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients used entekavir or TDF for Hepatitis B prophylaxis

Exclusion Criteria:

• Patients lower then 18 years old.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Reactivation

Locations

Country	Name	City	State
Turkey	Cerrahpasa Medical Faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Viral Hepatitis Society

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactivation Rate	Percentage of patients reactivated during the Entekavir or TDF	12 months