A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B
NCT ID: NCT01671787
Last Updated: 2018-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
51 participants
INTERVENTIONAL
2012-03-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GS-7340 8mg
After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days.
GS-7340
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
GS-7340 25mg
After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days.
GS-7340
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
GS-7340 40mg
After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days.
GS-7340
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
GS-7340 120mg
After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days.
GS-7340
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
Tenofovir disoproxil fumarate 300mg
After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days.
Tenofovir disoproxil fumarate
Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy
Interventions
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GS-7340
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
Tenofovir disoproxil fumarate
Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have Screening plasma HBV DNA ≥ 2x10\^3 IU/mL
* Must have chronic HBV infection for at least 6 months
* Must have estimated creatinine clearance (CLCr) ≥ 70 mL/min
* Not pregnant or nursing
* Women must be of non-childbearing potential OR of childbearing potential with confirmed negative pregnancy tests
* Consistent and correct use of recommended methods of birth control for men and women
Exclusion Criteria
* Receipt of anti-HBV nucleoside/nucleotide therapy. Subjects who have failed prior Interferon treatment, greater than 6 months prior to screening, are permitted to participate in the study screening
* Known co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
* Presence of autoimmune disorders
* History of liver disease other than Hepatitis B
* History of Gilbert's Disease
* Any sign of decompensated liver disease
* Known or suspected cirrhosis
* Evidence of hepatocellular carcinoma
* Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
* Electrolyte abnormalities
* History of treatment that permanently alters the gastric condition
* Alcohol or substance abuse
* History of bleeding diathesis
* Significant bone disease
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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John Flaherty, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Research and Education Inc.
San Diego, California, United States
University of Maryland Institute of Human Virology
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Baylor College of Medicine - St. Luke's Episcopal Hospital
Houston, Texas, United States
Monash Medical Centre
Melborne, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Austin Health
Melbourne, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Downtown Infectious Diseases Clinic (University of British Columbia)
Vancouver, British Columbia, Canada
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Algorithme Pharma
Montreal, Quebec, Canada
Pro-recherche
Saint Romuald, Quebec, Canada
Auckland Clinical Studies
Auckland, , New Zealand
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Grahame Hayton Unit
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Institute of Liver Studies, King's College Hospital
London, , United Kingdom
Nottingham University Hospitals NHS Trust - Queens Medical Centre
Nottingham, , United Kingdom
Countries
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Other Identifiers
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GS-US-320-0101
Identifier Type: -
Identifier Source: org_study_id
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