To Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma
A Multicenter Study to Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma Patients With Isolated Anti-HBc-positivity Who Will be Treated With Rituximab Based Chemotherapy
1 other identifier
interventional
90
1 country
1
Brief Summary
The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV) reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to contribute to the establishment of an effective prevention strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 26, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedDecember 21, 2016
December 1, 2016
2.6 years
October 22, 2015
December 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBV reactivation: defined as an increase in HBV DNA at least 10 folds from nadir or reappearance of HBsA or HBeAg in blood during treatment.
after 48 week from the End of treatment
Secondary Outcomes (1)
Hepatitis flare: defined as elevation of HBV viral load more than 2,000IU/ml from the baseline or by the reappearance of HBsAg and elevation of ALT at least 100IU/ml from the baseline.
after 48 week from the End of treatment
Study Arms (2)
tenofovir for 24 weeks
EXPERIMENTAL* prophylactic (preemptive) treatment * 300mg for 24 weeks * once daily
tenofovir for 48 weeks
EXPERIMENTAL* prophylactic (preemptive) treatment * 300mg for 48 weeks * once daily
Interventions
Anti-HBc positive patients with Non-Hodgkin's lymphoma planned to receive rituximab based chemotherapy will be randomized to either Group A or Group B in a 1:1 ratio and will be monitored every 12 weeks from the start of treatment for up to 72 weeks after the end of chemotherapy (EOC).
Eligibility Criteria
You may qualify if:
- Age of ≥ 18 (Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy. / A woman of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of tenofovir. / If the Investigator obtains information concerning the pregnancy of a female patient, the Investigator must terminate the study drug immediately in that patient, and report the information to IRB in the same manner as for SAE reporting)
- CD 20 positive patients with Non-Hodgkin's lymphoma who are planned to receive anticancer treatment with rituximab based chemotherapy and A. ECOG performance status 0-2 B. Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L) C. Adequate hematological function: hemoglobin ≥ 9g/dL, absolute neutrophil count (ANC) ≥ 1,500/μL, platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma D. Expected residual life ≥ 6 months
- Serum HBsAg negative, anti-HCV negative, but anti-HBc positive
- ALT \< 80IU/mL, serum bilirubin \< 3.0mg/dL, unless abnormalities are due to liver involvement by lymphoma or tumor lysis syndrome
- Individuals who were given and understood detailed explanations about this study, voluntarily decided to participate in the study, and provided written informed consent
You may not qualify if:
- Child-Pugh class C
- Other chronic liver diseases such as autoimmune hepatitis or Wilson's disease
- Patient who has hypersensitivity to study drug
- Patient who has galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Patient who is pregnant or on lactating. Or who has plans for pregnant or lactation during study period even the partner of the male patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Gilead Sciencescollaborator
- Konkuk University Hospitalcollaborator
Study Sites (1)
Seoul National University
Seoul, ASI|KR|KS013, South Korea
Related Publications (1)
Jang H, Yu SJ, Lee HG, Kim TM, Lee YB, Cho EJ, Lee JH, Yoon JH, Kim YJ. Efficacy of Antiviral Prophylaxis up to 6 or 12 Months From Completion of Rituximab in Resolved Hepatitis B Patients: A Multicenter, Randomized Study. J Korean Med Sci. 2023 Jul 17;38(28):e216. doi: 10.3346/jkms.2023.38.e216.
PMID: 37463687DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoon Jun Kim, M.D., Ph.D.
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 26, 2015
Study Start
November 1, 2015
Primary Completion
June 1, 2018
Study Completion
September 1, 2018
Last Updated
December 21, 2016
Record last verified: 2016-12