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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01671787
First received: August 21, 2012
Last updated: June 17, 2013
Last verified: June 2013

August 21, 2012
June 17, 2013
March 2012
April 2013   (final data collection date for primary outcome measure)
Change in serum HBV DNA [ Time Frame: Up to Week 4 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01671787 on ClinicalTrials.gov Archive Site
  • Change in HBV DNA for tenofovir disoproxil fumarate (TDF) [ Time Frame: Up to Week 4 ] [ Designated as safety issue: No ]
    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.
  • Change in HBV DNA of GS-7340 through 28 days of therapy [ Time Frame: Up to week 4 ] [ Designated as safety issue: No ]
    Time weighted change from baseline to day 29 (DAVG4) in serum HBV DNA (log10 IU/mL)
  • 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 ] [ Designated as safety issue: No ]

    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/ET.
  • Safety and Tolerability of Therapy [ Time Frame: Up to week 4 ] [ Designated as safety issue: Yes ]
    Safety and tolerability is measured by the incidence of adverse events and graded laboratory abnormalities
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: GS-7340
    Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
    Other Name: GS-7340
  • Drug: Tenofovir disoproxil fumarate
    Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy
    Other Name: Viread
  • 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.
    Intervention: Drug: GS-7340
  • 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.
    Intervention: Drug: GS-7340
  • 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.
    Intervention: Drug: GS-7340
  • 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.
    Intervention: Drug: GS-7340
  • 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.
    Intervention: Drug: Tenofovir disoproxil fumarate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
April 2013
April 2013   (final data collection date for primary outcome measure)

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, HCV or 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   New Zealand,   United Kingdom
 
NCT01671787
GS-US-320-0101
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: John Flaherty, MD Gilead Sciences
Gilead Sciences
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP