HepatitisNCT02108444
Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients
An observational study of Hepatitis and Hepatitis B, run by Peking University at 1 site in China.
Trial summary
This study is a retrospective analysis to explore the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatitis, Hepatitis B, Lymphoma
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Mar 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lymphoma patients with hepatitis B virus infection diagnosed in Peking University Cancer Hospita
Who may be able to join
- treatment-naive patients with lymphoma
- patients with a history of previous exposure to hepatitis B virus (HBV): HBsAg or hepatitis B core antibody (anti-HBc) positive
Who cannot join
- HBsAg and HBcAb negative
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients With Hepatitis B Virus Infection
This study is a retrospective analysis to explore the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus infection.
Read the detailed description
All eligible patients received prophylactic antiviral therapy during and within 6 months after chemotherapy in previous sudy. We did not assign specific interventions to the subjects in this study. The primary endpoint of this study is the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy. The secondary endpoints include the incidence of hepatitis flare related to hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the tumor response rate, and overall survival rate.
- Conditions
- Hepatitis, Hepatitis B, Lymphoma, Hematologic Diseases
- Keywords
- hepatitis, hepatitis B, lymphoma, Hematologic Diseases
- Medical subject headings
- Hepatitis, Hepatitis B, Lymphoma, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group with HBV reactivation | group with hepatitis B virus reactivation | |
| group without HBV reactivation | group without hepatitis B virus reactivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of hepatitis B virus delayed reactivation
hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy
Measured: within one year after withdrawal of prophylactic antiviral therapy
Secondary outcomes (3)
the incidence of hepatitis B virus related hepatitis flare
the incidence of hepatitis B virus related hepatitis flare after withdrawal of prophylactic antiviral therapy
Measured: within one year after withdrawal of prophylactic antiviral therapy
Number of patients that achieve a tumor response
Measured: within one year after withdrawal of prophylactic antiviral therapy
overall survival rate
Measured: within one year after withdrawal of prophylactic antiviral therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startJan 2007
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Peking University
- Investigators
- Jun Zhu, MD., Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108444
- Sponsor's protocol ID
- PKU 2013-Autonomous-9
- Status last verified
- Jul 2014
- First submitted
- 30 Mar 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients With Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT02108444
- Acronym / sponsor ID
- PKU 2013-Autonomous-9
- Conditions
- Hepatitis, Hepatitis B, Lymphoma, Hematologic Diseases
- Keywords
- hepatitis, hepatitis B, lymphoma, Hematologic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Apr 2014 (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.
This study is a retrospective analysis to explore the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus infection.
Detailed description
All eligible patients received prophylactic antiviral therapy during and within 6 months after chemotherapy in previous sudy. We did not assign specific interventions to the subjects in this study. The primary endpoint of this study is the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy. The secondary endpoints include the incidence of hepatitis flare related to hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the tumor response rate, and overall survival rate.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with HBV reactivation | – | –group with hepatitis B virus reactivation |
| group without HBV reactivation | – | –group without hepatitis B virus reactivation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lymphoma patients with hepatitis B virus infection diagnosed in Peking University Cancer Hospita
Key inclusion criteria (2 listed)
- treatment-naive patients with lymphoma
- patients with a history of previous exposure to hepatitis B virus (HBV): HBsAg or hepatitis B core antibody (anti-HBc) positive
Key exclusion criteria (1 listed)
- HBsAg and HBcAb negative
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
the incidence of hepatitis B virus delayed reactivation
Time frame: within one year after withdrawal of prophylactic antiviral therapy
hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy
3 secondary outcomes
the incidence of hepatitis B virus related hepatitis flare
Time frame: within one year after withdrawal of prophylactic antiviral therapy
Number of patients that achieve a tumor response
Time frame: within one year after withdrawal of prophylactic antiviral therapy
overall survival rate
Time frame: within one year after withdrawal of prophylactic antiviral therapy
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 24 Jul 2014.
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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.
Jun Zhu, MD. study chair
Peking University Cancer Hospital & Institute
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 and Hepatitis B, run by Peking University at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 24 Jul 2014. 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 China. 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.
What does the primary outcome measure?
the incidence of hepatitis B virus delayed reactivation (time frame: within one year after withdrawal of prophylactic antiviral therapy). 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 24 Jul 2014.