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



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:10/25/2018
Start Date:March 2012
End Date:April 2013

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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

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

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.

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
We found this trial at
5
sites
Detroit, Michigan 48202
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Detroit, MI
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Baltimore, MD
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Houston, TX
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Melborne, Victoria 03168
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Melborne,
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San Diego, California 92105
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San Diego, CA
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