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

Primary Purpose

Hepatitis B, HBV

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Single Ascending Dose (SAD) Cohorts GS-9620
Multiple Ascending Dose (MAD) Cohorts
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Hepatitis, Hepatitis B, Hepatitis B Virus, HBV, GS-9620, Toll-like receptor (TLR)-7 Agonist

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Hospital
  • West Coast Clinical Trials, LLC
  • University of California Antiviral Research Center (AVRC)
  • Indiana University Medical Center
  • Tulane University Health Sciences Center
  • Beth Israel Deaconess Medical Center
  • Henry Ford Health System
  • Kansas City Gastroenterology and Hepatology
  • Weill Cornell Medical College
  • University Hospitals Case Medical Center
  • CRI Worldwide, LLC
  • Baylor College of Medicine
  • University of Utah
  • Nepean Hospital
  • Royal Brisbane and Women's Hospital
  • Monash University, Department of Medicine
  • Royal Perth Hospital
  • University of Calgary, Heritage Medical Research Center
  • University of Alberta Hospital
  • Algorithme Pharma, Inc.
  • Asan Medical Center
  • Seoul National University Hospital
  • Auckland Clinical Studies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

0.3mg GS-9620

1mg GS-9620

2mg GS-9620

4mg GS-9620

0.3mg GS-9620 QW x 2 doses

1mg GS-9620 QW x 2 doses

2mg GS-9620 QW x 2 doses

4mg GS-9620 QW x 2 doses

Arm Description

Outcomes

Primary Outcome Measures

Assessment of adverse events in single and multiple oral doses of GS-9620
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.

Secondary Outcome Measures

Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
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])
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
Antiviral activity will be evaluated by determination of HBV HBsAg and HBV viral load kinetics

Full Information

First Posted
April 30, 2012
Last Updated
November 13, 2013
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01590641
Brief Title
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, HBV
Keywords
Hepatitis, Hepatitis B, Hepatitis B Virus, HBV, GS-9620, Toll-like receptor (TLR)-7 Agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.3mg GS-9620
Arm Type
Experimental
Arm Title
1mg GS-9620
Arm Type
Experimental
Arm Title
2mg GS-9620
Arm Type
Experimental
Arm Title
4mg GS-9620
Arm Type
Experimental
Arm Title
0.3mg GS-9620 QW x 2 doses
Arm Type
Experimental
Arm Title
1mg GS-9620 QW x 2 doses
Arm Type
Experimental
Arm Title
2mg GS-9620 QW x 2 doses
Arm Type
Experimental
Arm Title
4mg GS-9620 QW x 2 doses
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Single Ascending Dose (SAD) Cohorts GS-9620
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Multiple Ascending Dose (MAD) Cohorts
Intervention Description
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)
Primary Outcome Measure Information:
Title
Assessment of adverse events in single and multiple oral doses of GS-9620
Description
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.
Time Frame
Periodically Through Week 25
Secondary Outcome Measure Information:
Title
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
Description
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.
Time Frame
Day 1 and Day 8
Title
Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])
Description
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
Time Frame
Up to Day 15
Title
Reduction of hepatitis B (HBV) viral load from baseline
Description
Antiviral activity will be evaluated by determination of HBV HBsAg and HBV viral load kinetics
Time Frame
Up to Day 15 and Follow-Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedetta Massetto, M.D.
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
West Coast Clinical Trials, LLC
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
University of California Antiviral Research Center (AVRC)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5121
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Kansas City Gastroenterology and Hepatology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
CRI Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Monash University, Department of Medicine
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Royal Perth Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
University of Calgary, Heritage Medical Research Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Algorithme Pharma, Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3P 3P1
Country
Canada
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Auckland Clinical Studies
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1142
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

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