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A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01590654
First received: April 30, 2012
Last updated: December 18, 2013
Last verified: December 2013

April 30, 2012
December 18, 2013
April 2012
November 2013   (final data collection date for primary outcome measure)
Assessment of adverse events in single and multiple oral doses of GS-9620 [ Time Frame: Periodically Day 1 to 6 months ] [ Designated as safety issue: Yes ]
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital signs measurements
Same as current
Complete list of historical versions of study NCT01590654 on ClinicalTrials.gov Archive Site
  • Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods [ Time Frame: Day 1 and Day 8 ] [ Designated as safety issue: No ]

    SAD and MAD Cohorts:serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose.

    Mad Cohorts: serial blood samples will also be collected on Day 8 at 0 (pre-dose), , 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.

  • Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs]) [ Time Frame: Days 1, 2, 3, 5, 8 ] [ Designated as safety issue: No ]

    Single ascending dose (SAD) Cohorts: Whole blood and serum for pharmacodynamic (PD) assessments (RNA and cytokine analysis) will be drawn on Day 1 at pre-dose, 8, 24 and 48 hours post-dose, and on Days 5 and Day 8

    Multiple ascending dose (MAD) Cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8 hours Postdose, Day 2, Day 3, and Day 5 Day 8: Pre-dose and 8 hours Post-dose, Day 9, 10, 12, and Day 15

  • Reduction of hepatitis B (HBV) viral load from baseline [ Time Frame: Screening, Baseline, Day 8 or 15 ] [ Designated as safety issue: No ]

    SAD cohort: HBsAg+ levels will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits.

    MAD cohorts: HBsAg+ levels will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-Dose, 9, 10, 15, and both Follow-Up Visits.

  • Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods [ Time Frame: Day 1 and Day 8 ] [ Designated as safety issue: No ]

    SAD and MAD Cohorts:serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose.

    Mad Cohorts: serial blood samples will also be collected on Day 8 at 0 (pre-dose), , 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.

  • Measurement of pharmacodynamic markers (cytokines and ISGs) [ Time Frame: Days 1, 2, 3, 5, 8 ] [ Designated as safety issue: No ]

    SAD Cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1 at pre-dose, 8, 24 and 48 hours post-dose, and on Days 5 and Day 8

    MAD Cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8 hours Postdose, Day 2, Day 3, and Day 5 Day 8: Pre-dose and 8 hours Post-dose, Day 9, 10, 12, and Day 15

  • Reduction of HBV viral load from baseline [ Time Frame: Screening, Baseline, Day 8 or 15 ] [ Designated as safety issue: No ]

    SAD cohort: HBsAg+ levels will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits.

    MAD cohorts: HBsAg+ levels will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-Dose, 9, 10, 15, and both Follow-Up Visits.

Not Provided
Not Provided
 
A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection

Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on days 1-3 and/or days 8-10. Follow-up visits are required periodically through day 43. Subjects with sustained reductions in HbsAg will be requested to return for additional follow-up follow-up visits at 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hepatitis B
  • Drug: Single Ascending Dose (SAD) Cohorts GS-9620
    This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
  • Drug: Multiple Ascending Dose (MAD) Cohorts GS-9620
    This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
  • Experimental: 0.3mg GS-9620
    Intervention: Drug: Single Ascending Dose (SAD) Cohorts GS-9620
  • Experimental: 1mg GS-9620
    Intervention: Drug: Single Ascending Dose (SAD) Cohorts GS-9620
  • Experimental: 2mg GS-9620
    Intervention: Drug: Single Ascending Dose (SAD) Cohorts GS-9620
  • Experimental: 4mg GS-9620
    Intervention: Drug: Single Ascending Dose (SAD) Cohorts GS-9620
  • Experimental: 0.3mg GS-9620 QW x 2 doses
    Intervention: Drug: Multiple Ascending Dose (MAD) Cohorts GS-9620
  • Experimental: 1mg GS-9620 QW x 2 doses
    Intervention: Drug: Multiple Ascending Dose (MAD) Cohorts GS-9620
  • Experimental: 2mg GS-9620 QW x 2 doses
    Intervention: Drug: Multiple Ascending Dose (MAD) Cohorts GS-9620
  • Experimental: 4mg GS-9620 QW x 2 doses
    Intervention: Drug: Multiple Ascending Dose (MAD) Cohorts GS-9620
Not Provided

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

Inclusion Criteria:

  • Chronic HBV infection for ≥ 6 months
  • Currently on treatment with at least 1 HBV approved oral drug (i.e. lamivudine, telbivudine, entecavir, adefovir, tenofovir) ≥ 3 months prior to screening
  • HBsAg ≥ 250 IU/mL
  • HBV DNA at below the level of quantitation (BLQ; to be confirmed at screening)
  • Absence of extensive bridging fibrosis (Metavir 3 or greater)or cirrhosis
  • Creatinine clearance ≥ 70 mL/min

Exclusion Criteria:

  • Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
  • History of Gilberts disease
  • Laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (TSH), or other evidence of hepatic decompensation
  • Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed
  • Evidence of hepatocellular carcinoma
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Korea, Republic of,   New Zealand
 
NCT01590654
GS-US-283-0102
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Benedetta Massetto, M.D. Gilead Sciences
Gilead Sciences
December 2013

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