Hepatitis B Virus Reactivation After Withdrawal of Prophy... | NCT02108444

Studies
Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients

NCT02108444

Sponsor

Peking University

Status

Completed

Last Update Posted

Jul 24, 2014Estimated

Enrollment

107Actual

Phase

Not provided

Conditions

Hepatitis
Hepatitis B
Lymphoma
Hematologic Diseases

Interventions

Not provided

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 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Dec 2013Actual

Completion Date

Mar 2014Actual

First Submitted Date

Mar 30, 2014

First Submission Date that Met QC Criteria

Apr 8, 2014

First Posted Date

Apr 9, 2014Estimated

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 22, 2014

Last Update Posted Date

Jul 24, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study is a retrospective analysis to explore the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus infection.

Detailed Description

All eligible patients received prophylactic antiviral therapy during and within 6 months after chemotherapy in previous sudy. We did not assign specific interventions to the subjects in this study. The primary endpoint of this study is the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy. The secondary endpoints include the incidence of hepatitis flare related to hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the tumor response rate, and overall survival rate.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group with HBV reactivation		group with hepatitis B virus reactivation
group without HBV reactivation		group without hepatitis B virus reactivation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of hepatitis B virus delayed reactivation	hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy	within one year after withdrawal of prophylactic antiviral therapy

Secondary Outcomes

Measure	Description	Time Frame
the incidence of hepatitis B virus related hepatitis flare	the incidence of hepatitis B virus related hepatitis flare after withdrawal of prophylactic antiviral therapy	within one year after withdrawal of prophylactic antiviral therapy
Number of patients that achieve a tumor response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

treatment-naive patients with lymphoma
patients with a history of previous exposure to hepatitis B virus (HBV): HBsAg or hepatitis B core antibody (anti-HBc) positive

Exclusion Criteria:

HBsAg and HBcAb negative

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

lymphoma patients with hepatitis B virus infection diagnosed in Peking University Cancer Hospita

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun Zhu, MD.	Peking University Cancer Hospital & Institute	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Cancer Hospital		Beijing	Beijing Municipality	100142	China

Condition Browse Module

MeSH Terms

ID	Term
D006505	Hepatitis
D006509	Hepatitis B
D008223	Lymphoma
D006402	Hematologic Diseases

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D000086982	Blood-Borne Infections
D003141	Communicable Diseases

Browse Leaves

Not provided

Browse Branches

Not provided