Entecavir Versus Lamivudine for Preventing the Risk of He... | NCT01914744

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

NCT01914744

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Aug 2, 2013Estimated

Enrollment

82Estimated

Phase

Phase 2

Conditions

Non-Hodgkin Lymphoma
Hepatitis B Reactivation

Interventions

Entecavir
Lamivudine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Mar 2, 2013

First Submission Date that Met QC Criteria

Jul 31, 2013

First Posted Date

Aug 2, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2013

Last Update Posted Date

Aug 2, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
entecavir	Experimental	entecavir 0.5 mg/day PO	Drug: Entecavir Drug: Lamivudine
lamivudine	Active Comparator	lamivudine 100 mg/day PO	Drug: Entecavir Drug: Lamivudine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Entecavir	Drug	entecavir 0.5 mg/day PO	entecavir lamivudine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence rate of HBV reactivation	Defined by increased level of HBV DNA	12 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence rate of hepatitis and HBV reactivation-related hepatitis	Defined by increased level of alanine transaminase	6 months
Incidence rate and median time of treatment delay due to hepatitis

Other Outcomes

Measure	Description	Time Frame
Incidence of drug resistance of viral variants		3 years

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ye Guo, MD	Contact	+86 21 64175590	8906	pattrick_guo@msn.com

Overall Officials

Name	Affiliation	Role
Ye Guo, MD	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Hospital	Recruiting	Shanghai	Shanghai Municipality	200032	China

Condition Browse Module

MeSH Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C413685	entecavir
D019259	Lamivudine

Ancestor Terms

ID	Term
D016047	Zalcitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided