A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B

Completed · Phase 1

Conditions studied: Chronic Hepatitis B

In brief

This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).

Key facts

Study ID

NCT01671787

Run by

Gilead Sciences

People needed

51

Starts

2012-03-01

Expected to finish

2013-04-01

Last updated by the study team

2018-10-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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