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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01671787
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: GS-7340 Drug: Tenofovir disoproxil fumarate Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Viread


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671787


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: John Flaherty, MD Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01671787    
Other Study ID Numbers: GS-US-320-0101
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: May 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Keywords provided by Gilead Sciences:
Hepatitis B
HBV
GS-7340
TDF
 Tenofovir disoproxil fumarate
Gilead
Viread
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
 Hepadnaviridae Infections
DNA Virus Infections
Chronic Disease
Disease Attributes
Pathologic Processes
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents