NCT01671787

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	GS-7340	Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
DRUG	Tenofovir disoproxil fumarate	Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-08-24
• Last updated: 2018-10-23

Locations

19 sites across 5 countries: United States, Australia, Canada, New Zealand, United Kingdom