A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B
A Phase 1b Randomized, Open Label, Active-Controlled Study to Assess the Safety, Viral Kinetics, and Anti-HBV Activity of GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B (CHB) Infection
1 other identifier
interventional
51
5 countries
19
Brief Summary
This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2012
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 21, 2012
CompletedFirst Posted
Study publicly available on registry
August 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedOctober 23, 2018
May 1, 2014
1.1 years
August 21, 2012
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in serum hepatitis B virus (HBV) DNA
Time-weighted average change from baseline through Week 4 (DAVG4) in serum HBV DNA (log10 IU/mL) for GS-7340 8-, 25-, 40 and 120-mg.
Up to Week 4
Secondary Outcomes (4)
Change in HBV DNA for tenofovir disoproxil fumarate (TDF)
Up to Week 4
Change in HBV DNA of GS-7340 through 28 days of therapy
Up to week 4
Pharmacokinetics (PK) of GS-7340 and/or tenofovir (TVF) following single and multiple doses of GS-7340 and TDF
Up to week 4
Safety and Tolerability of Therapy
Up to week 4
Study Arms (5)
GS-7340 8mg
EXPERIMENTALAfter 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 25mg
EXPERIMENTALAfter 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 40mg
EXPERIMENTALAfter 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 120mg
EXPERIMENTALAfter 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 300mg
EXPERIMENTALAfter 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.
Interventions
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy
Eligibility Criteria
You may qualify if:
- Must be between 18 and 65 years of age
- 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
You may not qualify if:
- Pregnant or lactating subjects
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (19)
Research and Education Inc.
San Diego, California, 92105, United States
University of Maryland Institute of Human Virology
Baltimore, Maryland, 21201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Baylor College of Medicine - St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Monash Medical Centre
Melborne, Victoria, 03168, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Austin Health
Melbourne, Victoria, 3084, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009, Australia
Downtown Infectious Diseases Clinic (University of British Columbia)
Vancouver, British Columbia, V6Z2C9, Canada
The Ottawa Hospital, General Campus
Ottawa, Ontario, K1H8L6, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Algorithme Pharma
Montreal, Quebec, H3P3P1, Canada
Pro-recherche
Saint Romuald, Quebec, G6W 8H1, Canada
Auckland Clinical Studies
Auckland, 1042, New Zealand
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B152TH, United Kingdom
Grahame Hayton Unit
London, E1 1BB, United Kingdom
University College London Hospital
London, NW1-2BU, United Kingdom
Institute of Liver Studies, King's College Hospital
London, SE5 9RS, United Kingdom
Nottingham University Hospitals NHS Trust - Queens Medical Centre
Nottingham, NG7 2UH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Flaherty, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2012
First Posted
August 24, 2012
Study Start
March 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
October 23, 2018
Record last verified: 2014-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.