Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:March 2014
End Date:January 23, 2018

Use our guide to learn which trials are right for you!

Collection of Plasma Samples From Individuals Initiating Therapy With Entecavir or Tenofovir for Chronic Hepatitis B Virus Infection for the Clinical Evaluation of the Aptima HBV Quant Assay

This non-interventional clinical study will be conducted to prospectively collect serial
plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy.
These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant
assay, which is used as an aid in the management of HBV-infected patients undergoing HBV
antiviral therapy.


Inclusion Criteria:

- The subject is chronically infected with HBV.The subject is treatment naïve and is
initiating HBV antiviral therapy with either entecavir or tenofovir as indicated in
the FDA approved label

- The subject will be considered treatment naïve if he/she had <12 weeks of oral
antiviral therapy with any nucleoside or nucleotide therapy

- The subject is at least 18 years of age at the time of enrollment

- Adequate medical records are available for collection of protocol-defined
demographics, baseline patient characteristics, medical history, virology and specific
laboratory results, and other information to verify enrollment criteria

- The subject and/or legally authorized representative is willing and able to provide
consent prior to providing a specimen(s)

Exclusion Criteria:

- Subject is in one of the following patient populations:

- Acute HBV infection

- Patients who are HBV immune tolerant

- Human immunodeficiency virus (HIV) and/or hepatitis C virus (HCV) co-infection

- Solid organ or bone marrow transplant recipients

- Renal failure or dialysis

- Evidence or history of hepatic decompensation

- Evidence or history of hepatocellular carcinoma

- Underlying liver disease other than HBV

- Receiving chemotherapy, immunosuppressive agents

- Subject is unsuitable for study participation based on the Investigator's decision
(eg, unlikely to comply with study visit schedule, significant medical complication)

- Participating in another investigational study that the Investigator believes might
interfere with the subject's participation in this study
We found this trial at
39
sites
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Kittichai Promrat, MD
Phone: 401-444-3575
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Daryl Lau, MD
Phone: 617-632-1070
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
5615 Kirby Dr.
Houston, Texas 77005
713-442-1223
Principal Investigator: Greg Galler, MD
?
mi
from
Houston, TX
Click here to add this to my saved trials
300 Community Drive
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: David Bernstein, MD
Phone: 516-562-4281
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Atlanta, Georgia 30309
Principal Investigator: Michael Galambos, MD
Phone: 404-355-3200
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78756
Principal Investigator: Imtiaz Alam, MD
Phone: 512-371-7702
?
mi
from
Austin, TX
Click here to add this to my saved trials
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Principal Investigator: Paul Thuluvath, MD
Phone: 410-976-4414
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Catonsville, Maryland 21228
Principal Investigator: Natarajan Ravendhran, MD
Phone: 410-737-0053
?
mi
from
Catonsville, MD
Click here to add this to my saved trials
Charlotte, North Carolina 28203
Principal Investigator: Philippe Zamor, MD
Phone: 704-355-6649
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Detroit, Michigan 48202
Principal Investigator: Kimberly Brown, MD
Phone: 313-916-8632
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Flushing, New York 11355
Principal Investigator: Sing Chan, MD
Phone: 718-886-6292
?
mi
from
Flushing, NY
Click here to add this to my saved trials
Garden Grove, California 92843
Principal Investigator: Dinh Dinh, MD
Phone: 562-860-8171
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Victor Ankoma-Sey, MD
Phone: 713-799-2667
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kingswood, New South Wales 2747
Principal Investigator: Martin Weltman, MD
Phone: +61247342087
?
mi
from
Kingswood,
Click here to add this to my saved trials
Lancaster, California 93534
Principal Investigator: Jatinder Pruthi, MD
Phone: 661-945-7853
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Principal Investigator: Amandeep Sahota, MD
Phone: 323-783-8977
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Michael Lucey, MD
Phone: 608-263-7322
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Aasim Sheikh, MD
Phone: 678-819-4272
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Miami, Florida 33136
Principal Investigator: Eugene Schiff, MD
Phone: 305-243-4615
?
mi
from
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37205
Principal Investigator: Robert Herring, M.D.
?
mi
from
Nashville, TN
Click here to add this to my saved trials
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Joseph Lim, MD
Phone: 678-819-4272
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Newark, New Jersey
Principal Investigator: Nikolaos Pyrsopoulos, MD
Phone: 973-972-5252
?
mi
from
Newark, NJ
Click here to add this to my saved trials
2014 Washington St
Newton, Massachusetts 02462
(617) 243-6000
Principal Investigator: Michelle Freshman, NP
Phone: 617-243-5480
Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
?
mi
from
Newton, MA
Click here to add this to my saved trials
Norfolk, Virginia 23502
Principal Investigator: Michael Ryan, MD
Phone: 757-466-0165
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma
Principal Investigator: Hany Elbeshbeshy, MD
Phone: 405-945-4952
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19141
Principal Investigator: Eyob Feyssa
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Abdullah Al-Osaimi, M.D.
Phone: 215-707-5067
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85006
Principal Investigator: Mark Wong, MD
Phone: 602-839-6211
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85013
Principal Investigator: Anita Kohli, MD
Phone: 602-406-2147
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Rialto, California 92377
Principal Investigator: Zeid Kayali, M.D.
?
mi
from
Rialto, CA
Click here to add this to my saved trials
Salt Lake City, Utah 84132
Principal Investigator: Juan Gallegos-Orozco, MD
Phone: 801-585-9155
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92120
Principal Investigator: Anders Nyberg, MD
Phone: 619-662-5400
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94115
Principal Investigator: Jeffery Fessell, MD
Phone: 415-833-4431
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Jose, California 95116
Principal Investigator: Huy Trinh, MD
Phone: 303-406-4116
?
mi
from
San Jose, CA
Click here to add this to my saved trials
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Principal Investigator: Charles Landis, MD
Phone: 206-744-7062
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Springfield, Massachusetts 01107
Principal Investigator: Claudia Martorell, MD
Phone: 413-747-5566
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Statesville, North Carolina 28677
Principal Investigator: Robert Reindollar, MD
Phone: 704-978-1144
?
mi
from
Statesville, NC
Click here to add this to my saved trials
Torrance, California 90505
Principal Investigator: Edward Piken, MD
Phone: 310-539-2055
?
mi
from
Torrance, CA
Click here to add this to my saved trials