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 |
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).
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.
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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials