NCT01765231

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B

Interventions

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

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-01-10
• Last updated: 2017-01-10

Locations

13 sites across 1 country: China