Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B
Intervention: GS-4774 (Drug); GS-9620 (Drug); Tenofovir disoproxil fumarate (TDF) (Drug)
Phase: N/A
Status: Enrolling by invitation
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s): Benedetta Massetto, MD, PhD, Study Director, Affiliation: Gilead Sciences
Summary
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).
Clinical Details
Official title: A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48Proportion of participants who remain HBsAg negative at Week 48
Secondary outcome: Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144Proportion of participants who achieve HBsAg loss at Weeks 48 and 144 Proportion of participants who remain HBsAg negative at Week 144 Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48 Proportions of participants with HBeAg loss and seroconversion at Week 144 Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48 Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144 Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144 Change from Baseline in HBV DNA at Weeks 48, 96, and 144
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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
Locations and Contacts
Auckland City Hospital, Auckland, New Zealand
University of California, Los Angeles, Los Angeles, California, United States
Huntington Medical Research Institute, Pasadena, California, United States
Kaiser Permanente, Sacramento, California, United States
Kaiser Permanente, San Diego, California, United States
Kaiser Permanente, San Francisco, California, United States
Silicon Valley Research Institute, San Jose, California, United States
University of Miami, Miami, Florida, United States
Northwestern University, Chicago, Illinois, United States
Digestive Disease Associates, PA, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
St. Louis University, St. Louis, Missouri, United States
Medical Procare, PLL, Flushing, New York, United States
North Shore - LIJ Health System, Manhasset, New York, United States
Bon Secours St. Mary's Hospital of Richmond, Newport News, Virginia, United States
Additional Information
Starting date: December 2014
Last updated: August 14, 2015
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