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

Phase 4

• Conditions: Hepatitis B
• Interventions: Drug: Entecavir prophylaxis; Drug: Observation arm

• Registration Number: NCT01765231
• Lead Sponsor: Peking University

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-08
• Last Update Posted: 2017-01-10
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entecavir prophylaxis	Entecavir prophylaxis	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.
Observation arm	Observation arm	Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Peking University Cancer Hospital & Institute; 🇨🇳 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

General Hospital of Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China

307 Hospital of the Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China

First Hospital affiliated to General Hospital of the Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China