Trial record 17 of 19 for:
PKU | Open Studies
Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy
This study is currently recruiting participants.
Verified January 2013 by Peking University
Sponsor:
Peking University
Information provided by (Responsible Party):
Jun Zhu, Peking University
ClinicalTrials.gov Identifier:
NCT01768195
First received: January 9, 2013
Last updated: January 12, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Drug: Entecavir prophylaxis |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Peking University:
Primary Outcome Measures:
- the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- the incidence of hepatitis B virus virological response [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
- the incidence of hepatitis B virus serological response [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
- the incidence of hepatitis B virus maintained response [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
- the incidence of hepatitis B virus sustained response [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
- the incidence of hepatitis B virus relapse and relapse related hepatitis [ Time Frame: from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Entecavir prophylaxis
Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of immunochemotherapy and/or chemotherapy, and will be continued until 12 months after completion of the immunochemotherapy and/or chemotherapy.
|
Drug: Entecavir prophylaxis
Entecavir 0.5mg daily from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy. In patients with low load of hepatitis B virus DNA(≤2000 IU/ml), rituximab will be administrated at the beginning of entecavir prophylaxis. And in patients with high load of hepatitis B virus DNA(>2000 IU/ml), rituximab will be administrated when hepatitis B virus DNA decreased to the level of 2000 IU/ml after entecavir prophylaxis. Other Name: Baraclude
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- treatment-naive patients with B-cell lymphoma
- HBsAg positive at baseline
- treated with rituximab-based immunochemotherapy
- life expectancy of more than 3 months
Exclusion Criteria:
- younger than 18 years old
- HBsAg negative at baseline
- pregnant or lactating women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768195
Contacts
| Contact: Jun Zhu | zj@bjcancer.org | |
| Contact: Yuqin Song | songyuqin622@sina.com |
Locations
| China, Beijing | |
| Peking University Cancer Hospital & Institute | Recruiting |
| Beijing, Beijing, China, 100142 | |
| Contact: Jun Zhu zj@bjcancer.org | |
| Contact: Yuqin Song songyuqin622@sina.com | |
| Principal Investigator: Jun Zhu | |
| Peking University First Hospital | Recruiting |
| Beijing, Beijing, China | |
| Contact: Hanyun Ren | |
| Principal Investigator: Hanyun Ren | |
| Peking University People's Hospital | Recruiting |
| Beijing, Beijing, China | |
| Contact: Xiaojun Huang | |
| Principal Investigator: Xiaojun Huang | |
| Peking University Third Hospital | Recruiting |
| Beijing, Beijing, China | |
| Contact: Xiaoyan Ke | |
| Principal Investigator: Xiaoyan Ke | |
| Peking Union Medical College Hospital | Recruiting |
| Beijing, Beijing, China | |
| Contact: Daobin Zhou | |
| Principal Investigator: Daobin Zhou | |
| Beijing Hospital | Recruiting |
| Beijing, Beijing, China | |
| Contact: Hui Liu | |
| Principal Investigator: Hui Liu | |
| General Hospital of Chinese People's Liberation Army | Recruiting |
| Beijing, Beijing, China | |
| Contact: Li Yu | |
| Principal Investigator: Li Yu | |
| First Hospital affiliated to General Hospital of the Chinese People's Liberation Army | Recruiting |
| Beijing, Beijing, China | |
| Contact: Xiaoxiong Wu | |
| Principal Investigator: Xiaoxiong Wu | |
| 307 Hospital of the Chinese People's Liberation Army | Recruiting |
| Beijing, Beijing, China | |
| Contact: Weijing Zhang | |
| Principal Investigator: Weijing Zhang | |
| 309 Hospital of the Chinese People's Liberation Army | Recruiting |
| Beijing, Beijing, China | |
| Contact: Liping Ye | |
| Principal Investigator: Liping Ye | |
| Aerospace Central Hospital | Recruiting |
| Beijing, Beijing, China | |
| Contact: Jingbo Wang | |
| Principal Investigator: Jingbo Wang | |
| Air Force General Hospital of the Chinese People's Liberation Army | Recruiting |
| Beijing, Beijing, China | |
| Contact: Mei Xue | |
| Principal Investigator: Mei Xue | |
| Cancer Institute & Hospital, Chinese Academy of Medical Sciences | Recruiting |
| Beijing, Beijing, China | |
| Contact: Yuankai Shi | |
| Principal Investigator: Yuankai Shi | |
Sponsors and Collaborators
Peking University
Investigators
| Principal Investigator: | Jun Zhu | Peking University Cancer Hospital & Institute |
More Information
No publications provided
| Responsible Party: | Jun Zhu, Peking University Cancer Hospital & Institute, Peking University |
| ClinicalTrials.gov Identifier: | NCT01768195 History of Changes |
| Other Study ID Numbers: | PKU-2012111304 |
| Study First Received: | January 9, 2013 |
| Last Updated: | January 12, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Peking University:
|
Lymphoma Hepatitis B Virus Therapeutic Uses Antiviral Agents rituximab |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Rituximab Entecavir Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013