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Antiviral

Antiviral Therapy for Hepatitis B in Cancer Patients

Phase 3
Waitlist Available
Led By Jessica P Hwang
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be diagnosed with stage I-III solid tumor malignancy; patients with only carcinoma in situ or with stage IV disease are excluded
Patients must have Zubrod performance status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial will study the effect of tenofovir alafenamide in preventing liver complications in patients with current or past HBV who are receiving anti-cancer therapy for solid tumors.

Who is the study for?
This trial is for adults with stage I-III solid tumors and past/current hepatitis B, who are about to start or have recently started cancer treatment. They must not have HIV, active hepatitis C, liver cancer, cirrhosis, or a history of certain other cancers within the last five years. Participants need functioning kidneys and liver (with specific test results), no recent antiviral HBV treatments, and they can't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests if tenofovir alafenamide can prevent liver complications in patients with current/past hepatitis B undergoing anti-cancer therapy for solid tumors. It's a phase III trial comparing this drug against best practice care to see if it reduces worsening of HBV during cancer treatment.See study design
What are the potential side effects?
Tenofovir alafenamide may cause side effects like nausea, diarrhea, headache, fatigue, dizziness and may affect kidney function over time. Rarely it could lead to bone thinning or changes in body fat distribution.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is at stage I, II, or III and is not just in situ or at stage IV.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I have recent (within 28 days) hepatitis B tests: HBsAg, anti-HBc, and anti-HBs.
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I do not have lymphoma, leukemia, or myeloma.
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I do not have liver cancer, cirrhosis, or any cancer that has spread to my liver.
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I have never received cancer treatment that includes anti-CD20.
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I have not undergone a stem cell transplant.
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I am planning to undergo systemic therapy for my solid tumor.
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I stopped all previous cancer treatments at least 1 day before joining this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time until adverse liver outcome, assessed by incidence of adverse liver outcome
Secondary outcome measures
Cancer therapy interruption
Death due to any cause
HBV reactivation rate
+3 more

Side effects data

From 2022 Phase 4 trial • 270 Patients • NCT03471624
1%
Hepatocellular carcinoma
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tenofovir Alafenamide for 24 Months

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group C (TAF, TDF, entecavir, usual care)Experimental Treatment4 Interventions
Patients receive TAF PO QD or TDF PO QD or entecavir PO QD at the discretion of the physician during usual care. Treatment continues for up to 6 months after discontinuation of usual care or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.
Group II: Group B (TAF, TDF, entecavir)Experimental Treatment3 Interventions
Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.
Group III: Group A (TAF, TDF, entecavir)Experimental Treatment3 Interventions
Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir Alafenamide
2017
Completed Phase 4
~1580
Tenofovir Disoproxil Fumarate
2005
Completed Phase 4
~2080
Entecavir
2003
Completed Phase 4
~3670

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,807 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,166 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,149 Total Patients Enrolled

Media Library

Tenofovir Alafenamide (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT03887702 — Phase 3
Cancer Research Study Groups: Group C (TAF, TDF, entecavir, usual care), Group B (TAF, TDF, entecavir), Group A (TAF, TDF, entecavir)
Cancer Clinical Trial 2023: Tenofovir Alafenamide Highlights & Side Effects. Trial Name: NCT03887702 — Phase 3
Tenofovir Alafenamide (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03887702 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many enrollees does this clinical trial have?

"That is correct, the information available on clinicaltrials.gov attests that this study is actively recruiting. The trial began on 2/21/2019, with the most recent update being on 9/23/2022. The research team is looking for 444 individuals spread out over 100 different sites."

Answered by AI

For what purpose is Tenofovir Alafenamide most often recommended?

"Tenofovir Alafenamide can be prescribed to patients who have virologically suppressed for 3 months, are taking tenofovir, and have experienced treatment failure."

Answered by AI

Are there multiple research facilities testing this hypothesis in urban areas?

"There are over one hundred participating medical centres in this study, including Kaiser Permanente Dublin in Dublin, Hawaii, Kaiser Permanente-Fontana in Fontana, Idaho, and Kaiser Permanente-Santa Rosa in Santa Rosa, Illinois."

Answered by AI

Has Tenofovir Alafenamide been cleared by the FDA?

"There is already some evidence of efficacy and several rounds of data affirming safety, so our team at Power gave Tenofovir Alafenamide a safety score of 3."

Answered by AI

What other scientific investigations have used Tenofovir Alafenamide?

"At the moment, there are a total of 137 ongoing studies related to Tenofovir Alafenamide with 33 trials currently in Phase 3. Although a significant number of these studies are taking place in Boylston, Massachusetts, there are 1,783 research sites located across the globe."

Answered by AI

Who else is applying?

What site did they apply to?
Broward Health Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors
2020. "Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03887702.
~1 spots leftby Apr 2025
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