Hepatitis BPhase 4NCT01765231
Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma
A Phase 4 study testing Entecavir prophylaxis and Observation arm in people with Hepatitis B, run by Peking University at 13 sites in China.
Trial summary
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Entecavir prophylaxis and Observation arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 13 sitesChina
- Study dates
- Jan 2013to Dec 2017
- Phase
- Phase 4
- 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
Who may be able to join
- treatment-naive patients with lymphoma
- HBsAg negative/HBcAb positive/hepatitis B virus DNA negative at baseline
- treated with chemotherapy and/or immunosuppressive therapy
- life expectancy of more than 3 months
Who cannot join
- younger than 18 years old
- HBsAg positive or HBcAb negative or hepatitis B virus DNA positive at baseline
- pregnant or lactating women
Trial locations and contacts
13 sites in 1 country.
Jun Zhu contact
Yuqin Song contact
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Jun Zhu, zj@bjcancer.org
Yuqin Song, songyuqin622@sina.com
- Recruiting
307 Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality
Weijing Zhang
Weijing Zhang
- Recruiting
309 Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality
Liping Ye
Liping Ye
- Recruiting
Aerospace Central Hospital
Beijing, Beijing Municipality
Jingbo Wang
Jingbo Wang
- Recruiting
Air Force General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality
Mei Xue
Mei Xue
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality
Hui Liu
Hui Liu
- Recruiting
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yuankai Shi
Yuankai Shi
- Recruiting
First Hospital affiliated to General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality
Xiaoxiong Wu
Xiaoxiong Wu
- Recruiting
General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality
Li Yu
Li Yu
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Daobin Zhou
Daobin Zhou
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Hanyun Ren
Hanyun Ren
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Xiaojun Huang
Xiaojun Huang
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Xiaoyan Ke
Xiaoyan Ke
About this study
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma.
Read the detailed description
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma are randomized into entecavir prophylaxis group or observation group. In entecavir prophylaxis group, entecavir 0.5 mg/day orally is initiate on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy. In observation group, entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
- Conditions
- Hepatitis B
- Being tested
- Entecavir prophylaxis, Observation arm
- Keywords
- Lymphoma, Hepatitis B virus, Therapeutic Uses, Antiviral Agents
- Medical subject headings
- Hepatitis B, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir prophylaxisDrug
Also called Baraclude
Entecavir 0.5mg daily from day 1 of antitumor therapy to at least 6 months after completing antitumor therapy
Observation armDrug
Also called Therapeutic entecavir group
Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
| Study group | Role | What they receive |
|---|---|---|
| Entecavir prophylaxis | Experimental | Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy. Receives: Drug: Entecavir prophylaxis |
| Observation arm | Active comparator | Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation. Receives: Drug: Observation arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis
Measured: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy
Secondary outcomes (1)
the incidence of hepatitis B virus maintained response, the incidence of hepatitis B virus sustained response, the incidence of hepatitis B virus relapse and hepatitis B virus relapse related hepatitis
Measured: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Peking University
- Investigators
- Jun Zhu, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765231
- Sponsor's protocol ID
- PKU-2012111305
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2013
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma
- ClinicalTrials.gov ID
- NCT01765231
- Acronym / sponsor ID
- PKU-2012111305
- Conditions
- Hepatitis B
- Keywords
- Lymphoma, Hepatitis B virus, Therapeutic Uses, Antiviral Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Jan 2013 (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 identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma.
Detailed description
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma are randomized into entecavir prophylaxis group or observation group. In entecavir prophylaxis group, entecavir 0.5 mg/day orally is initiate on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy. In observation group, entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entecavir prophylaxis | Experimental | Drug: Entecavir prophylaxisParticipants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy. |
| Observation arm | Active comparator | Drug: Observation armEntecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- treatment-naive patients with lymphoma
- HBsAg negative/HBcAb positive/hepatitis B virus DNA negative at baseline
- treated with chemotherapy and/or immunosuppressive therapy
- life expectancy of more than 3 months
Key exclusion criteria (3 listed)
- younger than 18 years old
- HBsAg positive or HBcAb negative or hepatitis B virus DNA positive at baseline
- pregnant or lactating women
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 |
|---|---|---|
| Entecavir prophylaxisAlso: BaracludeEntecavir 0.5mg daily from day 1 of antitumor therapy to at least 6 months after completing antitumor therapy | Drug | Entecavir prophylaxis |
| Observation armAlso: Therapeutic entecavir groupEntecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation. | Drug | Observation arm |
Primary outcome
the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis
Time frame: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy
1 secondary outcome
the incidence of hepatitis B virus maintained response, the incidence of hepatitis B virus sustained response, the incidence of hepatitis B virus relapse and hepatitis B virus relapse related hepatitis
Time frame: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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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 contact
Yuqin Song contact
Jun Zhu principal investigator
Peking University Cancer Hospital & Institute
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir prophylaxis and Observation arm in people with Hepatitis B, run by Peking University at 13 sites 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 4 inclusion and 3 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 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jun Zhu (zj@bjcancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis (time frame: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor 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 10 Jan 2017.