A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01590641
First received: April 30, 2012
Last updated: November 13, 2013
Last verified: November 2013

April 30, 2012
November 13, 2013
April 2012
September 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 Through Week 25 ] [ Designated as safety issue: Yes ]
Safety will be assessed during the study through the reporting of adverse events, by clinical laboratory tests, physical examinations including vital signs and ECGs at various time points during the study, and by documentation of concomitant medications throughout the study.
Same as current
Complete list of historical versions of study NCT01590641 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 ]

    Single ascending dose (SAD) and multiple ascending dose (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: Up to Day 15 ] [ Designated as safety issue: No ]

    SAD Cohorts: whole blood and serum for pharmacodynamic (PD) assessments (RNA and cytokine analysis) will be drawn on Day 1: pre-dose and 8-hr post dose, Day 2, Day 3, 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, Day 5, and Day 8: pre-dose and 8 hours post-dose, Day 9, Day 10, Day 12, and Day 15

  • Reduction of hepatitis B (HBV) viral load from baseline [ Time Frame: Up to Day 15 and Follow-Up ] [ Designated as safety issue: No ]
    Antiviral activity will be evaluated by determination of HBV HBsAg and HBV viral load kinetics
  • 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: Up to Day 15 ] [ Designated as safety issue: No ]

    SAD Cohorts: whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: pre-dose and 8-hr post dose, Day 2, Day 3, 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, Day 5, and Day 8: pre-dose and 8 hours post-dose, Day 9, Day 10, Day 12, and Day 15

  • Reduction of HBV viral load from baseline [ Time Frame: Up to Day 15 and Follow-Up ] [ Designated as safety issue: No ]
    Antiviral activity will be evaluated by determination of HBV HBsAg and HBV viral load kinetics
Not Provided
Not Provided
 
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple- Dose Ranging, Adaptive Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive 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 either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required periodically through day 43, and potential viral load follow-up visits at weeks 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
  • HBV
  • 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
    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
  • Experimental: 1mg GS-9620 QW x 2 doses
    Intervention: Drug: Multiple Ascending Dose (MAD) Cohorts
  • Experimental: 2mg GS-9620 QW x 2 doses
    Intervention: Drug: Multiple Ascending Dose (MAD) Cohorts
  • Experimental: 4mg GS-9620 QW x 2 doses
    Intervention: Drug: Multiple Ascending Dose (MAD) Cohorts
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
October 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic HBV infection ≥ 6 months
  • HBsAg ≥ 250 IU/mL
  • HBV treatment naïve
  • 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
Canada,   Korea, Republic of,   New Zealand,   United States,   Australia
 
NCT01590641
GS-US-283-0106
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Benedetta Massetto, M.D. Gilead Sciences
Gilead Sciences
November 2013

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