TDF and Entekavir - Hepatitis B Reactivation
Sponsor
Viral Hepatitis Society (Other)
Overall Status
Recruiting
CT.gov ID
NCT06049602
Collaborator
(none)
10,000
1
11.5
869.6
Study Details
Study Description
Brief Summary
This is a non-interventional retrospective multi-center study for the patients received Entekavir or TDF for Hepatitis B prophylaxis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
10000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Efficacy of TDF and Entekavir Prophylaxis at Hepatitis B Reactivation: Multi Center Retrospective Study
Actual Study Start Date
:
Jan 15, 2023
Anticipated Primary Completion Date
:
Dec 31, 2023
Anticipated Study Completion Date
:
Dec 31, 2023
Outcome Measures
Primary Outcome Measures
- Reactivation Rate [12 months]
Percentage of patients reactivated during the Entekavir or TDF
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients used entekavir or TDF for Hepatitis B prophylaxis
Exclusion Criteria:
- Patients lower then 18 years old.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cerrahpasa Medical Faculty | Istanbul | Turkey |
Sponsors and Collaborators
- Viral Hepatitis Society
Investigators
- Study Director: Ilker Kurkcu, Sentez CRO
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Viral Hepatitis Society
ClinicalTrials.gov Identifier:
NCT06049602
Other Study ID Numbers:
- IMMUNHEP
First Posted:
Sep 22, 2023
Last Update Posted:
Sep 22, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: