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NCT Number: NCT01671787

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

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

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Monash Medical Centre, Melborne, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GS-7340

Drug

Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.

Tenofovir disoproxil fumarate

Drug

Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy

Other names: Viread

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 24, 2012
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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