Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection



Status:Terminated
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:10/5/2017
Start Date:December 9, 2014
End Date:August 14, 2017

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A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection

This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the
HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only
individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).


Key Inclusion Criteria:

- Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more
than 120 days prior to Baseline (Day 1), except for participants from previous
Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their
last visit in that protocol.

- Must have the ability to understand and sign a written informed consent form, which
must be obtained prior to initiation of study procedures

- Must be willing and able to comply with the visit schedule and study requirements

- Must have documented HBV DNA < 2,000 IU/mL at time of screening visit, which shall
occur no later than 1 year post last study visit in GS-US-174-0149

- Must have documented hepatitis B surface antigen (HBsAg) negative status anytime
during participation in GS-US-174-0149 regardless of ongoing HBV treatment

Key Exclusion Criteria:

- Patient participating or planning to participate in another clinical study with an
investigational agent

- History of clinically-significant illness or any other major medical disorder that may
interfere with follow-up, assessments or compliance with the protocol

- Believed by the Study Investigator to be inappropriate for study participation for any
reason not otherwise listed

- Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm)
or for TDF retreatment, and have taken any HBV antiviral therapy since completion of
GS-US-174-0149

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
17
sites
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
2578
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Boston, MA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
2320
mi
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Miami, FL
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
1932
mi
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Ann Arbor, MI
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Baltimore, Maryland 21229
2297
mi
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Baltimore, MD
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Camperdown, New South Wales 2050
7516
mi
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Camperdown,
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303 East Superior Street
Chicago, Illinois 60611
1730
mi
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Chicago, IL
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
1965
mi
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Detroit, MI
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Flushing, New York
2442
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Flushing, NY
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
2572
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Honolulu, HI
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Manhasset, New York 11030
2448
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Manhasset, NY
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Newport News, Virginia 23602
2321
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Newport News, VA
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Philadelphia, Pennsylvania 19107
2375
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Philadelphia, PA
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Sacramento, California 95825
364
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Sacramento, CA
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Saint Louis, Missouri 63110
1570
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Saint Louis, MO
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San Diego, California 92120
103
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San Diego, CA
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San Francisco, California 94115
356
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San Francisco, CA
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San Jose, California 95128
314
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San Jose, CA
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