Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma

Hepatitis B Clinical Trial

Official title:

Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01765231
• Other study ID #: PKU-2012111305
• Status: Recruiting
• Phase: Phase 4
• First received: January 9, 2013
• Last updated: January 8, 2017
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Peking University
• Contact: Jun Zhu
• Email: zj[@]bjcancer.org
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Lymphoma

Intervention

Drug:
• Entecavir prophylaxis
Entecavir 0.5mg daily from day 1 of antitumor therapy to at least 6 months after completing antitumor therapy
• Observation arm
Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Locations

Country	Name	City	State
China	307 Hospital of the Chinese People's Liberation Army	Beijing	Beijing
China	309 Hospital of the Chinese People's Liberation Army	Beijing	Beijing
China	Aerospace Central Hospital	Beijing	Beijing
China	Air Force General Hospital of the Chinese People's Liberation Army	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Cancer Institute & Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	First Hospital affiliated to General Hospital of the Chinese People's Liberation Army	Beijing	Beijing
China	General Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Cancer Hospital & Institute	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis		from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy	Yes
Secondary	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		from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy	Yes