Hepatitis BPhase 3NCT02186574
Tenofovir to Prevent HBV Reactivation
A Phase 3 study testing Tenofovir disoproxil in people with Hepatitis B and Lymphoma, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Lymphoma, Non-Hodgkin
- What is being tested?
- Tenofovir disoproxil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 2 sitesCanada
- Study dates
- May 2015to Feb 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy
- HBsAg negative, anti-HBc positive
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 1 recruiting
- Active, not recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Nimisha Dave, BSc, 416-946-4501 ext. 4753, nimisha.dave@uhn.ca
Ruth Turner, RN, 416-946-2987, ruth.turner@uhn.ca
About this study
Official title: A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia
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
- Being tested
- Tenofovir disoproxil, Placebo Oral Tablet
- Keywords
- Non-Hodgkin, Lymphoma, Hepatitis B, Tenofovir, Viread
- Medical subject headings
- Hepatitis B, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxilDrug
Also called Viread
Placebo Oral TabletDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Pre-emptive tenofovir | Active comparator | Tenofovir disoproxil Receives: Drug: Tenofovir disoproxil |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-chemotherapy
Secondary outcomes (8)
Rates of HBV Reactivation
Measured: 12 months post-chemotherapy
Severe HBV-associated hepatitis
Measured: 12 months post-chemotherapy
HBV-related liver failure
Measured: 12 months post-chemotherapy
Liver-related death
Measured: 12 months post-chemotherapy
Treatment-related adverse effects (AEs)
Measured: 12 months post-chemotherapy
Time to start chemotherapy
Measured: 12 months post-chemotherapy
Chemotherapy interruption
Measured: 12 months post-chemotherapy
All-cause mortality
Measured: 12 months post-chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startMay 2015
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry Janssen, MD, Study director, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186574
- Sponsor's protocol ID
- JF62014
- Status last verified
- Dec 2019
- First submitted
- 7 Jul 2014
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41335575
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT02186574
- Acronym / sponsor ID
- JF62014
- Conditions
- Hepatitis B, Lymphoma, Non-Hodgkin
- Keywords
- Non-Hodgkin, Lymphoma, Hepatitis B, Tenofovir, Viread
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-emptive tenofovir | Active comparator | Drug: Tenofovir disoproxilTenofovir disoproxil |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy
- HBsAg negative, anti-HBc positive
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir disoproxilAlso: Viread | Drug | Pre-emptive tenofovir |
| Placebo Oral TabletAlso: Placebo | Drug | Placebo |
Primary outcome
Rate of reverse seroconversion
Time frame: 12 months post-chemotherapy
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.
8 secondary outcomes
Rates of HBV Reactivation
Time frame: 12 months post-chemotherapy
Severe HBV-associated hepatitis
Time frame: 12 months post-chemotherapy
HBV-related liver failure
Time frame: 12 months post-chemotherapy
Liver-related death
Time frame: 12 months post-chemotherapy
Treatment-related adverse effects (AEs)
Time frame: 12 months post-chemotherapy
Time to start chemotherapy
Time frame: 12 months post-chemotherapy
Chemotherapy interruption
Time frame: 12 months post-chemotherapy
All-cause mortality
Time frame: 12 months post-chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Derived from this study: PubMed 41335575Tabataba 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Janssen, MD study director
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenofovir disoproxil in people with Hepatitis B and Lymphoma, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordan Feld, MD (416-340-4584, jordan.feld@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reverse seroconversion (time frame: 12 months post-chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02186574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.