Tenofovir to Prevent HBV Reactivation

NCT ID: NCT02186574

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2021-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B Lymphoma Non-Hodgkin

Keywords

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Non-Hodgkin Lymphoma Hepatitis B Tenofovir Viread

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pre-emptive tenofovir

Tenofovir disoproxil

Group Type ACTIVE_COMPARATOR

Tenofovir disoproxil

Intervention Type DRUG

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Interventions

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Tenofovir disoproxil

Intervention Type DRUG

Placebo Oral Tablet

Intervention Type DRUG

Other Intervention Names

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Viread Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry Janssen, MD

Role: STUDY_DIRECTOR

University Health Network, Toronto

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jordan Feld, MD

Role: CONTACT

Phone: 416-340-4584

Email: [email protected]

Jamuna Nanthakumar, CCRP

Role: CONTACT

Phone: 416-340-4800

Email: [email protected]

Facility Contacts

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Nimisha Dave, BSc

Role: primary

Ruth Turner, RN

Role: backup

Other Identifiers

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JF62014

Identifier Type: -

Identifier Source: org_study_id