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Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL

NCT ID: NCT01914744

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-12-31

Brief Summary

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The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.

Detailed Description

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In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.

Conditions

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Non-Hodgkin Lymphoma Hepatitis B Reactivation

Keywords

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NHL HBV entecavir lamivudine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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entecavir

entecavir 0.5 mg/day PO

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

entecavir 0.5 mg/day PO

Lamivudine

Intervention Type DRUG

lamivudine 100 mg/day PO

lamivudine

lamivudine 100 mg/day PO

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

entecavir 0.5 mg/day PO

Lamivudine

Intervention Type DRUG

lamivudine 100 mg/day PO

Interventions

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Entecavir

entecavir 0.5 mg/day PO

Intervention Type DRUG

Lamivudine

lamivudine 100 mg/day PO

Intervention Type DRUG

Other Intervention Names

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baraclude epivir

Eligibility Criteria

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Inclusion Criteria

* Previously untreated NHL suitable for CHOP/R-CHOP treatment
* Age range 18-80 years old
* HBsAg positive with high level of HBV DNA
* Eastern Cooperative Oncology Group performance status 0-2
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria

* Primary or secondary central nervous system involvement
* With hepatitis C virus infection
* Previous serious cardiac disease
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ye Guo

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ye Guo, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ye Guo, MD

Role: CONTACT

Phone: +86 21 64175590

Email: [email protected]

Facility Contacts

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Ye Guo, MD

Role: primary

Other Identifiers

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LMTG 13-03

Identifier Type: -

Identifier Source: org_study_id