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Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP (IHBVRL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Junning Cao, Fudan University
ClinicalTrials.gov Identifier:
NCT01210287
First received: September 27, 2010
Last updated: January 7, 2014
Last verified: January 2014

September 27, 2010
January 7, 2014
October 2010
August 2014   (final data collection date for primary outcome measure)
incidence of HBV reactivation [ Time Frame: from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP ] [ Designated as safety issue: Yes ]
HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).
incidence of HBV reactivation [ Time Frame: from the first cycle of RCHOP to six months after the last cycle of RCHOP ] [ Designated as safety issue: Yes ]
HBV reacivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).
Complete list of historical versions of study NCT01210287 on ClinicalTrials.gov Archive Site
the outcome of antiviral therapy in HBV-DNA abnormal patients [ Time Frame: from the initiation of antiviral thearpy to six months after the last cycle of RCHOP ] [ Designated as safety issue: Yes ]
Once the level of HBV-DNA exceeds the upper limit of normal, antiviral therapy will be given immediately.Liver function and serum HBsAg and HBcAg of these patients will be monitored until six months after the last dosing of RCHOP.
the outcomes of antiviral therapy [ Time Frame: from the initiation of antiviral thearpy to six months after the last cycle of RCHOP ] [ Designated as safety issue: Yes ]
Once the level of HBV-DNA exceeds the upper limit of normal, antiviral therapy will be given immediately.
Not Provided
Not Provided
 
Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP
Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study

The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Lymphoma
Drug: nucleoside analog reverse transcriptase inhibitor
tablets 100mg qd
Other Name: lamivudine
No Intervention: Observation
Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.
Intervention: Drug: nucleoside analog reverse transcriptase inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Naive DLBCL or high grade FL patients
  • Age range 18-75 years old
  • ECOG performance status 0-3
  • Life expectancy of more than 3 months
  • Adequate organ function
  • HBsAg negative/HBcAb positive at baseline

Exclusion Criteria:

  • Infection of HAV,HCV,HIV
  • Pregnant or lactating women
  • Serious uncontrolled diseases
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01210287
201010HBV
Yes
Junning Cao, Fudan University
Fudan University
Not Provided
Principal Investigator: Junning Cao, Doctor member of Fudan University
Fudan University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP