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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: GS-7340 (Drug); Tenofovir disoproxil fumarate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
John Flaherty, MD, Study Director, Affiliation: Gilead Sciences


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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in serum hepatitis B virus (HBV) DNA

Secondary outcome:

Change in HBV DNA for tenofovir disoproxil fumarate (TDF)

Change in HBV DNA of GS-7340 through 28 days of therapy

Pharmacokinetics (PK) of GS-7340 and/or tenofovir (TVF) following single and multiple doses of GS-7340 and TDF

Safety and Tolerability of Therapy

Detailed description: This is a randomized, open-label, active-controlled study whose primary objective is to evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the safety, viral kinetics, and antiviral activity of 4 different doses of GS-7340 over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of GS-7340 versus 300mg Tenofovir disoproxil fumarate (TDF) over 28 days of therapy.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Locations and Contacts

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

Institute of Liver Studies, King's College Hospital, London SE5 9RS, United Kingdom

University College London Hospital, London NW1-2BU, United Kingdom

Nottingham University Hospitals NHS Trust - Queens Medical Centre, Nottingham NG7 2UH, United Kingdom

Downtown Infectious Diseases Clinic (University of British Columbia), Vancouver, British Columbia V6Z2C9, Canada

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

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, St. Romuald, Quebec G6W 8H1, Canada

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

Additional Information

Starting date: March 2012
Last updated: May 8, 2014

Page last updated: August 23, 2015

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