Clinical trial NCT01765231: Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma
Official title: Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Keywords: Lymphoma
Hepatitis B virus
Therapeutic Uses
Antiviral Agents
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* younger than 18 years old
* HBsAg positive or HBcAb negative or hepatitis B virus DNA positive at baseline
* pregnant or lactating women

Primary outcomes:
measure: the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis
timeFrame: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy
Secondary outcomes:
measure: 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
timeFrame: from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
city: Beijing
country: China
facility: 307 Hospital of the Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: 309 Hospital of the Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Aerospace Central Hospital
state: Beijing
city: Beijing
country: China
facility: Air Force General Hospital of the Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Institute & Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: First Hospital affiliated to General Hospital of the Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: General Hospital of Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu
role: PRINCIPAL_INVESTIGATOR
References: