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

October 19, 2018 updated by: Gilead Sciences

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melborne, Victoria, Australia, 03168
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research Ltd
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z2C9
        • Downtown Infectious Diseases Clinic (University of British Columbia)
    • Ontario
      • Ottawa, Ontario, Canada, K1H8L6
        • The Ottawa Hospital, General Campus
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3P3P1
        • Algorithme Pharma
      • St. Romuald, Quebec, Canada, G6W 8H1
        • Pro-Recherche
  • New Zealand
      • Auckland, New Zealand, 1042
        • Auckland Clinical Studies
  • United Kingdom
      • Birmingham, United Kingdom, B152TH
        • University Hospitals Birmingham NHS Foundation Trust
      • London, United Kingdom, E1 1BB
        • Grahame Hayton Unit
      • London, United Kingdom, NW1-2BU
        • University College London Hospital
      • London, United Kingdom, SE5 9RS
        • Institute of Liver Studies, King's College Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust - Queens Medical Centre
  • United States
    • California
      • San Diego, California, United States, 92105
        • Research and Education Inc.
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Institute of Human Virology
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - St. Luke's Episcopal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GS-7340 8mg
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.
Drug: GS-7340
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
Experimental: GS-7340 25mg
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.
Drug: GS-7340
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
Experimental: GS-7340 40mg
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.
Drug: GS-7340
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
Experimental: GS-7340 120mg
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.
Drug: GS-7340
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
Experimental: Tenofovir disoproxil fumarate 300mg
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.
Drug: Tenofovir disoproxil fumarate
Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy
Other Names:
  • Viread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum hepatitis B virus (HBV) DNA
Time Frame: Up to Week 4
Time-weighted average change from baseline through Week 4 (DAVG4) in serum HBV DNA (log10 IU/mL) for GS-7340 8-, 25-, 40 and 120-mg.
Up to Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HBV DNA for tenofovir disoproxil fumarate (TDF)
Time Frame: Up to Week 4
Comparing the short-term antiviral activity of GS-7340 with TDF 300mg. This is measured by time-weighted average change from baseline through Week 4 (DAVG4) in serum HBV DNA (log10 IU/mL) for TDF.
Up to Week 4
Change in HBV DNA of GS-7340 through 28 days of therapy
Time Frame: Up to week 4
Time weighted change from baseline to day 29 (DAVG4) in serum HBV DNA (log10 IU/mL)
Up to week 4
Pharmacokinetics (PK) of GS-7340 and/or tenofovir (TVF) following single and multiple doses of GS-7340 and TDF
Time Frame: Up to week 4

GS-7340 and tenofovir (TFV) PK parameters in plasma will be calculated as applicable: Cmax, Tmax, Clast, Tlast, T1/2, λz, AUC0-t, AUC0-last, AUC0-∞, %AUCexp.

PK samples are collected on:

  • Baseline/Day 1: 0 (predose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose
  • Additional predose plasma samples will be collected on Days 2, 5, 8, 10, 15, 19, 22, and 29/End of Treatment.
Up to week 4
Safety and Tolerability of Therapy
Time Frame: Up to week 4
Safety and tolerability is measured by the incidence of adverse events and graded laboratory abnormalities
Up to week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: John Flaherty, MD, Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

August 23, 2012

First Posted (Estimate)

August 24, 2012

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-320-0101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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