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A Multicenter, Randomized, Open-label 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

A Multicenter, Randomized, Open-label 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003072
Enrollment
90
Registered
2018-08-07
Start date
2015-11-26
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Drug: Tenofovir (daily 300mg, oral) Group A: Upon the EOC, subjects will receive tenofovir 300mg for approximately 6 months (24 weeks) and undergo treatment and follow-up every 12 weeks for up

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age of = 18 2. CD 20 positive patients with Non-Hodgkin's lymphoma who are planned to receive anticancer treatment with rituximab based chemotherapy and A. ECOG(Eastern Cooperative Oncology Group) 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 3. Serum HBsAg negative, anti-HCV negative, but anti-HBc positive 4. ALT < 80IU/mL, serum bilirubin < 3.0mg/dL, unless abnormalities are due to liver involvement by lymphoma or tumor lysis syndrome 5. Individuals who were given and understood detailed explanations about this study, voluntarily decided to participate in the study, and provided written informed consent

Exclusion criteria

Exclusion criteria: 1. Child-Pugh class C 2. Other chronic liver diseases such as autoimmune hepatitis or Wilson's disease 3. Patient who has hypersensitivity to study drug 4. Patient who has galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption 5. 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

Design outcomes

Primary

MeasureTime frame
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.—

Secondary

MeasureTime frame
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.—

Countries

Korea, Republic of

Contacts

Public ContactYOONJUN KIM

Seoul National University Hospital

anyes1118@daum.net+82-2-2072-3081

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026