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Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B

NCT01943799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2019-11-01

Study results available
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Summary

The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.

Conditions

  • Chronic HBV Infection

Interventions

BIOLOGICAL

GS-4774

Administered as a subcutaneous injection every 4 weeks for a total of 6 doses

DRUG

OAV Regimen

Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-13
Primary Completion
2014-09-09
Completion
2015-03-03
FDA Drug
Yes

Countries

  • United States
  • New Zealand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01943799 on ClinicalTrials.gov