NCT06049602

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

12 months

First QC Date

September 15, 2023

Last Update Submit

September 15, 2023

Conditions

Hepatitis B Reactivation

Outcome Measures

Primary Outcomes (1)

  • Reactivation Rate

    Percentage of patients reactivated during the Entekavir or TDF

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who used entekavir or TDF for Hepatitis B prophylaxis

You may qualify if:

  • Patients used entekavir or TDF for Hepatitis B prophylaxis

You may not qualify if:

  • Patients lower then 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

  • Ilker Kurkcu

    Sentez CRO

    STUDY DIRECTOR

Central Study Contacts

Fehmi Tabak, Prof

CONTACT

+905322763788fehmitabak@yahoo.com

Ilker Kurkcu

CONTACT

+905326354515ilker.kurkcu@sentez-cro.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 22, 2023

Study Start

January 15, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)