AzTrials
AzTrials

Hepatitis B InfectionPhase 3NCT03887702

Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors

A Phase 3 study testing Best Practice, Entecavir and Tenofovir Alafenamide in people with Hepatitis B Infection and Malignant Solid Neoplasm, run by SWOG Cancer Research Network at 193 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase III trial studies the effect of hepatitis B antiviral (anti-HBV) therapy in preventing liver complications in patients with chronic or past hepatitis B virus (HBV) who are receiving anti-cancer therapy for solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Best Practice, Entecavir and Tenofovir Alafenamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
193 sitesin 2 countries
Study dates
17 Jan 2020to 20 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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 not have lymphoma, leukemia, or myeloma
  • Patients must not have primary liver cancer, known cirrhosis, or evidence of any malignancy that involves the liver
  • Patients must be planning to receive systemic anti-cancer therapy (either single agent or some combination of systemic cytotoxic therapy, systemic immunotherapy or systemic targeted therapy) for this solid tumor
  • Patients must not have been previously treated with the same anti-cancer therapy regimen that is now anticipated; the anti-cancer therapy does not have to be first-line therapy; prior and/or concurrent radiotherapy is allowed
  • Patients must be registered <= 28 days prior to the planned start date of anti-cancer therapy; if the patient has started systemic anti-cancer therapy, patient must be registered <= 42 days after the initiation of first cycle of anti-cancer therapy
Show all 30Show fewer
  • Patients who have received prior anti-cancer therapy must have discontinued all previous therapies (excluding planned anti-cancer therapy to occur in conjunction with this study) >= 1 day prior to registration to this study
  • Patients must not have had any cancer therapy regimen that includes anti-CD20
  • Patients must not be receiving antiviral medications active against HBV, including: adefovir, entecavir, lamivudine, telbivudine, tenofovir disoproxil fumarate, tenofovir alafenamide (TAF), or any other Food and Drug Administration (FDA) approved agents for the treatment of hepatitis B; patients who have previously received antiviral medication must not have required any antiviral medication active against HBV >= 90 days prior to registration to this study
  • Patients must not have had hematopoietic stem cell transplantation therapy
  • Patients must not be taking or planning to take warfarin
  • Patients who will be treated with TAF must not be taking or planning to take oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John's Wort
  • Patients who will be treated with TAF and are concomitantly taking or plan to take carbamazepine must be given an increased dose of TAF or alternatively be given ETV or TDF
  • Patients must have results for the following HBV tests done within 28 days prior to registration: HBsAg AND anti-HBc (total immunoglobulin [Ig] or IgG, but not IgM only) AND hepatitis B surface antibody (anti-HBs); for the anti-HBs test, quantitative or qualitative (including "indeterminate") results are allowable
  • Patients must have tested positive for HBsAg or anti-HBc (total Ig, IgG, but not IgM) and must have baseline HBV deoxyribonucleic acid (DNA) completed <= 42 days prior to registration
  • Complete blood count (CBC) must be completed <= 28 days prior to registration; results do not need to be in the institutional limits of normal
  • International normalized ratio (INR) must be completed <= 28 days prior to registration; results must <= 1.2 x institutional limits of normal
  • Alanine aminotransferase (ALT) must be obtained <= 28 days prior to registration; ALT must be < 1.5 x institutional ULN
  • Total bilirubin must be obtained <= 28 days prior to registration; total bilirubin must be < 1.5 x institutional ULN
  • Creatinine results must be obtained <= 28 days prior to registration
  • Patients must not have known current active hepatitis C infection (HCV); active HCV is defined by a detectable HCV ribonucleic acid (RNA) level; Note: HCV testing is not required for eligibility
  • Patients must not have a history of human immunodeficiency (HIV) infection; patients with unknown HIV status must have HIV testing completed <= 365 days prior to registration
  • Patients must have Zubrod performance status of 0-2
  • Patients must not be pregnant or nursing, as the safety of the study drug in pregnant and nursing women has not been established; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must have specimens collected for submission as outlined
  • Patients must be offered the opportunity to participate in optional translational medicine studies as outlined
  • Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)
  • Patients may have concurrent participation in other clinical trials that entail cytotoxic, immunotherapy, targeted therapy; surgical treatment; radiotherapy treatment; or any combination thereof
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Who cannot join

None listed.

Trial locations and contacts

193 sites in 2 countries.

193 sites in 2 countries

United States192 sites

  • Hawaii Cancer Care - Savio

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Northwestern University

    Chicago, Illinois, 60611

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Broward Health North

    Deerfield Beach, Florida, 33064

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Epic Care-Dublin

    Dublin, California, 94568

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Fresno Cancer Center

    Fresno, California, 93720

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Kaiser Permanente - Harbor City

    Harbor City, California, 90710

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Island Urology

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Hawaii Diagnostic Radiology Services LLC

    Honolulu, Hawaii, 96817

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Kansas Institute of Medicine Cancer and Blood Center

    Lenexa, Kansas, 66219

  • Minimally Invasive Surgery Hospital

    Lenexa, Kansas, 66219

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Tibor Rubin VA Medical Center

    Long Beach, California, 90822

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

  • Ochsner LSU Health Monroe Medical Center

    Monroe, Louisiana, 71202

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Saint Alphonsus Medical Center-Nampa

    Nampa, Idaho, 83686

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • USC Norris Oncology/Hematology-Newport Beach

    Newport Beach, California, 92663

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Kaiser Permanente Oakland-Broadway

    Oakland, California, 94611

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

  • Saint Alphonsus Medical Center-Ontario

    Ontario, Oregon, 97914

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Keck Medical Center of USC Pasadena

    Pasadena, California, 91105

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Kaiser Permanente-Rancho Cordova Cancer Center

    Rancho Cordova, California, 95670

  • Kaiser Permanente-Redwood City

    Redwood City, California, 94063

  • Kaiser Permanente-Richmond

    Richmond, California, 94801

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • The Permanente Medical Group-Roseville Radiation Oncology

    Roseville, California, 95678

  • Kaiser Permanente Downtown Commons

    Sacramento, California, 95814

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

  • South Sacramento Cancer Center

    Sacramento, California, 95823

  • Kaiser Permanente - Sacramento

    Sacramento, California, 95825

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

  • Kaiser Permanente San Leandro

    San Leandro, California, 94577

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92078

  • Kaiser Permanente-San Rafael

    San Rafael, California, 94903

  • Kaiser San Rafael-Gallinas

    San Rafael, California, 94903

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Kaiser Permanente Washington

    Seattle, Washington, 98112

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103

  • Kaiser Permanente Cancer Treatment Center

    South San Francisco, California, 94080

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, 94080

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Mercy Hospital South

    St Louis, Missouri, 63128

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Kaiser Permanente-Stockton

    Stockton, California, 95210

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Kaiser Permanente Medical Center-Vacaville

    Vacaville, California, 95688

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596

  • Epic Care Cyberknife Center

    Walnut Creek, California, 94597

  • Mercy Hospital Washington

    Washington, Missouri, 63090

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Kaiser Permanente-Woodland Hills

    Woodland Hills, California, 91367

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

  • Rush-Copley Healthcare Center

    Yorkville, Illinois, 60560

Other trials in United States

Guam1 site

  • FHP Health Center-Guam

    Tamuning, 96913

Other trials in Guam

About this study

Official title: A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors

This phase III trial studies the effect of hepatitis B antiviral (anti-HBV) therapy in preventing liver complications in patients with chronic or past hepatitis B virus (HBV) who are receiving anti-cancer therapy for solid tumors. People with chronic or past HBV who are undergoing therapy for cancer are at an increased risk for changes in the liver which could be minor or severe. Anti-HBV therapy acts against infections caused by HBV and may help reduce the chance that HBV gets worse or comes back in patients receiving anti-cancer therapy for solid tumors.

Read the detailed description

Co-Primary Objectives

  1. To compare the effect of prophylactic anti-HBV therapy versus upon indication anti-HBV therapy on time-to-adverse liver outcomes of liver failure or liver-related death in patients with chronic HBV infection (HBsAg+ and anti-HBc+) receiving anti-cancer therapy for solid tumors.
  2. To compare the effect of upon indication anti-HBV therapy versus usual care on time-to-adverse liver outcomes of liver failure or liver-related death in patients with past HBV infection (HBsAg- and anti-HBc+) receiving anti-cancer therapy for solid tumors.

Secondary Objectives

  1. Using time-to-event analysis, to compare the effect of anti-HBV therapy versus upon indication anti-HBV therapy on HBV reactivation, on the combined endpoint of adverse liver outcomes (liver failure or liver-related death) and HBV reactivation, and on HBV flare by arm in patients with chronic HBV infection receiving anticancer therapy for solid tumors.
  2. Using time-to-event analysis, to compare the effect of upon indication anti-HBV therapy versus usual care on HBV reactivation, on the combined endpoint of adverse liver outcomes (liver failure or liver-related death) and HBV reactivation, and on HBV flare by arm in patients with past HBV infection receiving anti-cancer therapy for solid tumors.

Translational Objectives

  1. To compare baseline and changes in overall immune status and HBV-specific immune response in patients with solid tumors and chronic or past HBV infection receiving anti-cancer therapy, and to compare the differences in these immune responses by HBV reactivation status.
  2. To identify demographic and clinical predictors and correlative immunologic biomarkers of HBV reactivation after receipt of anti-cancer therapy in patients with solid tumors and chronic or past HBV infection.

OUTLINE: Patients are recruited in two cohorts (Cohort 1: chronic HBV infection, Cohort 2: past HBV infection), with each cohort randomized equally to one of two potential treatment arms.

Chronic HBV Infection (Cohort 1) Arms:

Arm 1: Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (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.

Arm 2: 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.

Past HBV infection (Cohort 2) Arms:

Arm 3: 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.

Arm 4: Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for HBV may be used.

(Cohort 1: Arm 2 and Cohort 2: Arm 3 follow the same treatment plan, but are considered part of separate parallel studies and are therefore identified as separate arms.)

Patients are followed for 24 months: every 4 weeks from randomization to week 24, then every 8 weeks thereafter up to week 104.

Being tested
Best Practice, Entecavir, Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive best practice

  • EntecavirDrug

    Also called Baraclude, BMS-200475-01, ETV, SQ-34676

    Given PO

  • Tenofovir AlafenamideDrug

    Also called GS 7340, GS-7340, TFV Alafenamide

    Given PO

  • Tenofovir Disoproxil FumarateDrug

    Also called PMPA Prodrug, TDF, Tenofovir DF, Viread

    Given PO

Study groups in NCT03887702
Study groupRoleWhat they receive
Arm 1 (TAF, TDF, entecavir: prophylactic)Experimental[Cohort 1] 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.
Receives: Drug: Entecavir; Drug: Tenofovir Alafenamide; Drug: Tenofovir Disoproxil Fumarate
Arm 2 (TAF, TDF, entecavir: upon indication)Experimental[Cohort 1] 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.
Receives: Drug: Entecavir; Drug: Tenofovir Alafenamide; Drug: Tenofovir Disoproxil Fumarate
Arm 3 (TAF, TDF, entecavir: upon indication)Experimental[Cohort 2] 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.
Receives: Drug: Entecavir; Drug: Tenofovir Alafenamide; Drug: Tenofovir Disoproxil Fumarate
Arm 4 (Anti-Viral therapy: usual care)Active comparator[Cohort 2] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.
Receives: Other: Best Practice; Drug: Entecavir; Drug: Tenofovir Alafenamide; Drug: Tenofovir Disoproxil Fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Liver Outcome

    Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review.

    Measured: From randomization to 24 months

Secondary outcomes (3)

  1. Number of Participants With Hepatitis B Virus (HBV) Reactivation

    HBV reactivation is is defined as one of the following:

    • ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or
    • HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or
    • HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or
    • HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-.

    Measured: From randomization up to 24 months

  2. Number of Participants With Hepatitis B Virus (HBV) Flare

    Hepatitis flare is defined as ALT > 3 x baseline and >100 U/L.

    Measured: From randomization to 24 months

  3. Combined Endpoint of Adverse Liver Outcomes and HBV Reactivation, Number of Participants

    Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review.

    HBV reactivation is defined as one of the following:

    • ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or
    • HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or
    • HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or
    • HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-.

    The combined endpoint of adverse liver outcomes and HBV reactivation is the occurrence of either adverse liver outcome or HBV reactivation as defined above.

    Measured: From randomization to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start17 Jan 2020
  3. Primary completion20 Dec 2022
  4. Study completion20 Dec 2022

Why it stopped: inability to accrue

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03887702
Sponsor's protocol ID
S1614
Other IDs
NCI-2018-00592, S1614, SWOG-S1614, S1614, UG1CA189974
Status last verified
May 2024
First submitted
21 Mar 2019
Last updated
20 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Best Practice, Entecavir and Tenofovir Alafenamide in people with Hepatitis B Infection and Malignant Solid Neoplasm, run by SWOG Cancer Research Network at 193 sites in 2 countries.

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 30 inclusion and 0 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: stopped early, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in United States, Guam. 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. 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?

Yes. Results are posted in the registry (first posted 20 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Liver Outcome (time frame: From randomization to 24 months). 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 NCT03887702.

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 20 May 2024.

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