NCT02186574

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

5.8 years

First QC Date

July 7, 2014

Last Update Submit

December 10, 2019

Conditions

Hepatitis BLymphomaNon-Hodgkin

Keywords

Non-HodgkinLymphomaHepatitis BTenofovirViread

Outcome Measures

Primary Outcomes (1)

  • Rate of reverse seroconversion

    The difference in the rate of reverse seroconversion or Hepatitis B (HBV)-associated hepatitis (definition: appearance of HBsAg in the serum with or without detectable HBV DNA in a patient who was previously HBsAg-/cAb+.) between the intervention and placebo groups.

    12 months post-chemotherapy

Secondary Outcomes (8)

  • Rates of HBV Reactivation

    12 months post-chemotherapy

  • Severe HBV-associated hepatitis

    12 months post-chemotherapy

  • HBV-related liver failure

    12 months post-chemotherapy

  • Liver-related death

    12 months post-chemotherapy

  • Treatment-related adverse effects (AEs)

    12 months post-chemotherapy

  • +3 more secondary outcomes

Study Arms (2)

Pre-emptive tenofovir

ACTIVE COMPARATOR

Tenofovir disoproxil

Drug: Tenofovir disoproxil

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Oral Tablet

Interventions

Tenofovir disoproxilDRUG
Also known as: Viread
Pre-emptive tenofovir
Placebo Oral TabletDRUG
Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

ACTIVE NOT RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Publications (1)

  • Tabataba Vakili S, Hirode G, Zahoor A, Saunthar A, Feld JB, Hansen BE, Syeda A, Janssen HLA, Kukreti V, Kuruvilla J, Prica A, Cheung M, Buckstein R, Hicks L, Coffin CS, Street LE, Disperati P, Chan KK, Crump M, Feld JJ. Tenofovir alafenamide for prevention of HBV reactivation in HBsAg-negative, anti-HBc-positive patients undergoing rituximab-based chemotherapy: A multicenter randomized controlled trial. Hepatol Commun. 2025 Dec 3;9(12):e0859. doi: 10.1097/HC9.0000000000000859. eCollection 2025 Dec 1.

    PMID: 41335575DERIVED

MeSH Terms

Conditions

Hepatitis BLymphoma

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Harry Janssen, MD

    University Health Network, Toronto

    STUDY DIRECTOR

Central Study Contacts

Jordan Feld, MD

CONTACT

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

Jamuna Nanthakumar, CCRP

CONTACT

416-340-4800jnanthak@uhnresearch.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 10, 2014

Study Start

May 1, 2015

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations

CA(2)