Hepatitis B ReactivationNCT06049602
TDF and Entekavir - Hepatitis B Reactivation
An observational study of Hepatitis B Reactivation, run by Viral Hepatitis Society at 1 site in Turkey (Türkiye).
Trial summary
This is a non-interventional retrospective multi-center study for the patients received Entekavir or TDF for Hepatitis B prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B Reactivation
- How many people
- 10,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who used entekavir or TDF for Hepatitis B prophylaxis
Who may be able to join
- Patients used entekavir or TDF for Hepatitis B prophylaxis
Who cannot join
- Patients lower then 18 years old.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cerrahpasa Medical Faculty
Istanbul
Fehmi Tabak, Prof, fehmitabak@yahoo.com
Fehmi Tabak, Prof.
About this study
Official title: Efficacy of TDF and Entekavir Prophylaxis at Hepatitis B Reactivation: Multi Center Retrospective Study
This is a non-interventional retrospective multi-center study for the patients received Entekavir or TDF for Hepatitis B prophylaxis.
- Conditions
- Hepatitis B Reactivation
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactivation Rate
Percentage of patients reactivated during the Entekavir or TDF
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start15 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B ReactivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viral Hepatitis Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilker Kurkcu, Study director, Sentez CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049602
- Sponsor's protocol ID
- IMMUNHEP
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of TDF and Entekavir Prophylaxis at Hepatitis B Reactivation: Multi Center Retrospective Study
- ClinicalTrials.gov ID
- NCT06049602
- Acronym / sponsor ID
- IMMUNHEP
- Conditions
- Hepatitis B Reactivation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Viral Hepatitis SocietyUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-interventional retrospective multi-center study for the patients received Entekavir or TDF for Hepatitis B prophylaxis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who used entekavir or TDF for Hepatitis B prophylaxis
Key inclusion criteria (1 listed)
- Patients used entekavir or TDF for Hepatitis B prophylaxis
Key exclusion criteria (1 listed)
- Patients lower then 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reactivation Rate
Time frame: 12 months
Percentage of patients reactivated during the Entekavir or TDF
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B Reactivation
Not yet recruitingObservational study
HBV Reactivation Prediction Model in Allo-HSCT
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Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody)
Resolved Hepatitis B, CD20 Positive B-cell Lymphoma
Active, not recruitingPhase 4
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
Chronic Hepatitis b, Hepatitis B Reactivation
Active, not recruitingObservational study
Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.
Occult Hepatitis B Infection in Cancer Patients
Enrolling by invitation
Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
Hepatitis B Reactivation, Hematopoietic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilker Kurkcu study director
Sentez CRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B Reactivation, run by Viral Hepatitis Society at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fehmi Tabak, Prof (+905322763788, fehmitabak@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactivation Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.