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

Primary Purpose

Hepatitis C

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

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis, Hepatitis C, Chronic HCV, HCV, Treatment Naive, Gilead, GS-9620

Eligibility Criteria

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

Inclusion Criteria:

  • Males and Females 18-65 years old
  • Chronic HCV infection for at least 6 months, treatment naive
  • HCV Viral load > 100,000 IU/mL at Screening
  • Monoinfection with HCV 1 genotype
  • Hepatitis B surface antigen negative
  • Screening ECG without clinically significant abnormalities
  • BMI 18-33 kg/m^2
  • Creatinine clearing > 70 mL/min
  • Negative pregnancy test at screening

Exclusion Criteria:

  • Pregnant or lactating subjects
  • Co-infection with hepatitis B virus (HBV) or HIV
  • History of Gilberts disease
  • Particular abnormal laboratory parameters
  • Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
  • Evidence of hepatocellular carcinoma
  • On-going alcohol abuse
  • Positive uring drug screen

Sites / Locations

  • Woodland International Research Group
  • Avail Clinical Research, LLC
  • Orlando Clinical Research Center
  • Kansas City Gastroenterology and Hepatology
  • Comprehensive Clinical Research
  • CRI Worldwide, LLC
  • CliniLabs
  • CRI Worldwide, LLC
  • Alamo Medical Research
  • Lifetree Clinical Research
  • Fundacion De Investigacion De Diego

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

Incidence of adverse events in single and multiple doses of GS-9620
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements

Secondary Outcome Measures

Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
Single ascending dose (SAD) 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. Multiple ascending dose (MAD) cohorts: serial blood samples will 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-hour Post-dose, Day 2, Day 3, Day 5, 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 Post-dose, Day 2, Day 3, Day 5, Day 8: Pre-dose and 8 hours Post-dose, Day 9, Day 10, Day 12, and Day 15
Reduction of hepatitis C (HCV) RNA viral load from baseline
SAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits. MAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-dose, 9, 10, 15, and both Follow-Up Visits.

Full Information

First Posted
March 23, 2012
Last Updated
August 12, 2013
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01591668
Brief Title
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
Official Title
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 Treatment Naive Subjects With Chronic Hepatitis C Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (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 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples 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 C
Keywords
Hepatitis, Hepatitis C, Chronic HCV, HCV, Treatment Naive, Gilead, GS-9620

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (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 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. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
Intervention Type
Drug
Intervention Name(s)
Multiple Ascending Dose 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 Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
Primary Outcome Measure Information:
Title
Incidence of adverse events in single and multiple doses of GS-9620
Description
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements
Time Frame
Periodically Day 1 to 6 months
Secondary Outcome Measure Information:
Title
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
Description
Single ascending dose (SAD) 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. Multiple ascending dose (MAD) cohorts: serial blood samples will 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-hour Post-dose, Day 2, Day 3, Day 5, 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 Post-dose, Day 2, Day 3, Day 5, Day 8: Pre-dose and 8 hours Post-dose, Day 9, Day 10, Day 12, and Day 15
Time Frame
Days 1, 2, 3, 5, 8
Title
Reduction of hepatitis C (HCV) RNA viral load from baseline
Description
SAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits. MAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-dose, 9, 10, 15, and both Follow-Up Visits.
Time Frame
Screening, Baseline, Day 8 or 15

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: Males and Females 18-65 years old Chronic HCV infection for at least 6 months, treatment naive HCV Viral load > 100,000 IU/mL at Screening Monoinfection with HCV 1 genotype Hepatitis B surface antigen negative Screening ECG without clinically significant abnormalities BMI 18-33 kg/m^2 Creatinine clearing > 70 mL/min Negative pregnancy test at screening Exclusion Criteria: Pregnant or lactating subjects Co-infection with hepatitis B virus (HBV) or HIV History of Gilberts disease Particular abnormal laboratory parameters Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed Evidence of hepatocellular carcinoma On-going alcohol abuse Positive uring drug screen
Facility Information:
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
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
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
CRI Worldwide, LLC
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
CliniLabs
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
CRI Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Fundacion De Investigacion De Diego
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
25105516
Citation
Lawitz E, Gruener D, Marbury T, Hill J, Webster L, Hassman D, Nguyen AH, Pflanz S, Mogalian E, Gaggar A, Massetto B, Subramanian GM, McHutchison JG, Jacobson IM, Freilich B, Rodriguez-Torres M. Safety, pharmacokinetics and pharmacodynamics of the oral toll-like receptor 7 agonist GS-9620 in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2015;20(7):699-708. doi: 10.3851/IMP2845. Epub 2014 Aug 8.
Results Reference
derived

Learn more about this trial

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

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