Hepatitis B VirusNCT00876148
Risk of Hepatitis B Virus Reactivation in Patients Undergoing Allografting
An observational study of Hepatitis B Virus and Allograft, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the risk of hepatitis B reactivation in patients undergoing allografting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis B Virus, Allograft, Hematological Malignancies
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of patients undergoing allografting for hematological malignancies
Who may be able to join
- All patients undergoing an allograft for hematological malignancies
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the risk of hepatitis B reactivation in patients undergoing allografting.
- Conditions
- Hepatitis B Virus, Allograft, Hematological Malignancies
- Keywords
- Incidence of hepatitis B after allografting, Risk of hepatitis B reactivation, Lamivudine prophylaxis
- Medical subject headings
- Hepatitis B, Hematologic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B VirusStudies 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
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876148
- Sponsor's protocol ID
- LAM Allo SCT
- Status last verified
- Apr 2009
- First submitted
- 3 Apr 2009
- Last updated
- 6 Apr 2009
- Results posted
- No
Publications
Giaccone L, Festuccia M, Marengo A, Resta I, Sorasio R, Pittaluga F, Fiore F, Boccadoro M, Rizzetto M, Bruno B, Marzano A. Hepatitis B virus reactivation and efficacy of prophylaxis with lamivudine in patients undergoing allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2010 Jun;16(6):809-17. doi: 10.1016/j.bbmt.2009.12.533. Epub 2010 Jan 7.
PubMed 20060484
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Hepatitis B Virus Reactivation in Patients Undergoing Allografting
- ClinicalTrials.gov ID
- NCT00876148
- Acronym / sponsor ID
- LAM Allo SCT
- Conditions
- Hepatitis B Virus, Allograft, Hematological Malignancies
- Keywords
- Incidence of hepatitis B after allografting, Risk of hepatitis B reactivation, Lamivudine prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- First posted
- 6 Apr 2009 (estimated)
- 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.
The purpose of this study is to evaluate the risk of hepatitis B reactivation in patients undergoing allografting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of patients undergoing allografting for hematological malignancies
Key inclusion criteria (1 listed)
- All patients undergoing an allograft for hematological malignancies
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2009.
- Derived from this study: PubMed 20060484Giaccone L, Festuccia M, Marengo A, Resta I, Sorasio R, Pittaluga F, Fiore F, Boccadoro M, Rizzetto M, Bruno B, Marzano A. Hepatitis B virus reactivation and efficacy of prophylaxis with lamivudine in patients undergoing allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2010 Jun;16(6):809-17. doi: 10.1016/j.bbmt.2009.12.533. Epub 2010 Jan 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Virus and Allograft, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
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 0 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: finished, as of the sponsor's last update on 6 Apr 2009. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876148, which also lists 1 linked publication.
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 6 Apr 2009.