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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: Tenofovir disoproxil fumarate; Drug: GS-7340

Study type: Interventional

Funder types: Industry

Identifiers

NCT01671787

GS-US-320-0101

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 5 patient groups

GS-7340 8mg

Experimental group

Description:

After 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.

Treatment:

Drug: GS-7340

GS-7340 25mg

Experimental group

Description:

After 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.

Treatment:

Drug: GS-7340

GS-7340 40mg

Experimental group

Description:

After 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.

Treatment:

Drug: GS-7340

GS-7340 120mg

Experimental group

Description:

After 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.

Treatment:

Drug: GS-7340

Tenofovir disoproxil fumarate 300mg

Experimental group

Description:

After 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.

Treatment:

Drug: Tenofovir disoproxil fumarate