Recruiting
Phase 3

Tenofovir

Sponsor:

University Health Network, Toronto

Code:

NCT02186574

Conditions

Hepatitis B

Lymphoma

Non-Hodgkin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tenofovir disoproxil

Placebo Oral Tablet

Study Details

Brief summary:

The purpose of the study is to determine how effective preemptive tenofovir therapy is in preventing the re-activation of Hepatitis B infection, in patients who are receiving rituximab-based chemotherapy for Non-Hodgkin's Lymphoma or CLL/SLL. The rate of re-activation will be compared between patients who receive preemptive tenofovir and patients who receive tenofovir as needed.

Conditions

Hepatitis B

Lymphoma

Non-Hodgkin

Study ID

NCT02186574

Start date

May, 2015

Status verified date

Dec, 2019

Completion date

Feb, 2021

Anticipated

Primary completion date

Feb, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥ 18 years of age
2. Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy
3. HBsAg negative, anti-HBc positive

Exclusion Criteria:

1. Current therapy with known activity against HBV
2. Screening ALT > 10 x ULN
3. Screening ALT >2 and <10 xULN with HBV DNA > 2000 IU/mL (indicates active HBV infection despite HBsAg negative and require antiviral therapy)
4. Life expectancy < 3 months
5. HBsAg positive
6. HIV co-infection
7. Active HCV co-infection (HCV RNA positive)
8. Creatinine clearance <50 mL/min
9. Intolerance to tenofovir
10. Women of child-bearing potential unwilling to take contraception during the study period

Study Design

Enrollment

184 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pre-emptive tenofovir

Tenofovir disoproxil

placebo comparator: Placebo

Placebo

Interventions

Tenofovir disoproxil

Placebo Oral Tablet

Primary outcome measure

  • Rate of reverse seroconversion [ Time Frame: 12 months post-chemotherapy ]

Central Contacts and Locations

Central contacts

Jordan Feld, MD

416-340-4584jordan.feld@uhn.ca

Jamuna Nanthakumar, CCRP

416-340-4800jnanthak@uhnresearch.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Nimisha Dave, BSc

416-946-4501nimisha.dave@uhn.ca

Ruth Turner, RN

416-946-2987ruth.turner@uhn.ca

Principal Investigator:

Michael Crump, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 12, 2019

Last verified

Dec, 2019

Keywords

  • Non-Hodgkin
  • Lymphoma
  • Hepatitis B
  • Tenofovir
  • Viread

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2019-12-12.