Resolved Hepatitis BPhase 2REHEBNCT05453435
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)
A Phase 2 study testing Entecavir in people with Resolved Hepatitis B and CD20 Positive B-cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 6 months after completing CD20 monoclonal antibody therapy in patients with CD20-positive B-cell lymphomas and resolved hepatitis B (negative hepatitis B surface antigen, positive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resolved Hepatitis B, CD20 Positive B-cell Lymphoma
- What is being tested?
- Entecavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Histopathologically confirmed CD20 positive B-cell lymphoma;
- Plan to receive first-line anti-lymphoma therapy containing CD20 monoclonal antibodies;
- Negative HBsAg, HBV-DNA lower than the detection limit and positive anti-HBC at baseline;
- Total bilirubin less than 1.5X the upper limit of normal (ULN), AST and ALT less than 2.5X ULN;
- ECOG PS: 0~2;
- Estimated survival time >3 months.
Who cannot join
- Positive HBsAg or HBV-DNA higher than the detection limit at baseline;
- Previous chemotherapy or radiotherapy for lymphoma;
- Other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, Wilson' s disease or primary biliary cirrhosis;
- Pregnant or lactating women;
- History of immunodeficiency, including positive HIV, or other acquired congenital immunodeficiency disease, or history of organ transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, State..., 510060
About this study
Official title: 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) (REHEB)：a Single Arm, Open Label, Multi-center Phase II Study
This phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 6 months after completing CD20 monoclonal antibody therapy in patients with CD20-positive B-cell lymphomas and resolved hepatitis B (negative hepatitis B surface antigen, positive hepatitis B core antibody).
- Being tested
- Entecavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
All patients enrolled in the study will accept entecavir prophylaxis that initiates within 1 week before the first course of CD20 monoclonal antibody therapy, and continues until 6 months after completing CD20 monoclonal antibody therapy.
| Study group | Role | What they receive |
|---|---|---|
| Entecavir prophylaxis | Experimental | 0.5mg qd Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative HBV reactivation rate
Cumulative incidence of hepatitis B virus reactivation
Measured: 12 months
Secondary outcomes (2)
Incidence of HBV-related liver failure
Incidence of HBV-related liver failure
Measured: 12 months
Incidence of HBV-related chemotherapy disruption
Incidence of HBV-related chemotherapy disruption
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 posted12 Jul 2022
- Study start15 Jul 2022
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resolved Hepatitis BStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453435
- Sponsor's protocol ID
- B2022-352-01
- Acronym
- REHEB
- Status last verified
- May 2026
- First submitted
- 2 Jul 2022
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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) (REHEB)：a Single Arm, Open Label, Multi-center Phase II Study
- ClinicalTrials.gov ID
- NCT05453435
- Acronym / sponsor ID
- REHEB / B2022-352-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Jul 2022 (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 phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 6 months after completing CD20 monoclonal antibody therapy in patients with CD20-positive B-cell lymphomas and resolved hepatitis B (negative hepatitis B surface antigen, positive hepatitis B core antibody).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entecavir prophylaxis | Experimental | Drug: Entecavir0.5mg qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed CD20 positive B-cell lymphoma;
- Plan to receive first-line anti-lymphoma therapy containing CD20 monoclonal antibodies;
- Negative HBsAg, HBV-DNA lower than the detection limit and positive anti-HBC at baseline;
- Total bilirubin less than 1.5X the upper limit of normal (ULN), AST and ALT less than 2.5X ULN;
- ECOG PS: 0~2;
Key exclusion criteria (5 listed)
- Positive HBsAg or HBV-DNA higher than the detection limit at baseline;
- Previous chemotherapy or radiotherapy for lymphoma;
- Other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, Wilson' s disease or primary biliary cirrhosis;
- Pregnant or lactating women;
- History of immunodeficiency, including positive HIV, or other acquired congenital immunodeficiency disease, or history of organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntecavirAll patients enrolled in the study will accept entecavir prophylaxis that initiates within 1 week before the first course of CD20 monoclonal antibody therapy, and continues until 6 months after completing CD20 monoclonal antibody therapy. | Drug | Entecavir prophylaxis |
Primary outcome
Cumulative HBV reactivation rate
Time frame: 12 months
Cumulative incidence of hepatitis B virus reactivation
2 secondary outcomes
Incidence of HBV-related liver failure
Time frame: 12 months
Incidence of HBV-related chemotherapy disruption
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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?
A Phase 2 study testing Entecavir in people with Resolved Hepatitis B and CD20 Positive B-cell Lymphoma, run by Sun Yat-sen 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Cumulative HBV 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 May 2026.