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

This study is currently recruiting participants.

Verified December 2011 by Gilead Sciences

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT01590654

First received: April 30, 2012

Last updated: November 26, 2012

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2012

Last Updated Date

November 26, 2012

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01590654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis B

Intervention ^ICMJE

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).

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chronic HBV infection for ≥ 6 months
Currently on treatment with TDF ≥ 3 months prior to screening
HBsAg ≥ 250 IU/mL
HBV DNA < LLoQ for at least 3 months prior to screening
Absence of extensive bridging fibrosis (Metavir 3 or greater)or cirrhosis
BMI 18-33kg/m^2
Creatinine clearance ≥ 70mL/min

Exclusion Criteria:

Co-infection with HCV, HDV or HIV
History of Gilberts disease
Laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, TSH, or other evidence of hepatic decompensation
Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe COPD, malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed
Evidence of hepatocellular carcinoma

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Uri Lopatin, MD	650-522-5120	Uri.Lopatin@gilead.com
Contact: Benedetta Massetto, MD	650-522-5075	Benedetta.Massetto@gilead.com

Location Countries ^ICMJE

United States, Australia, Canada, New Zealand

Administrative Information

NCT Number ^ICMJE

NCT01590654

Other Study ID Numbers ^ICMJE

GS-US-283-0102

Has Data Monitoring Committee

Yes

Responsible Party

Gilead Sciences

Study Sponsor ^ICMJE

Gilead Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Gilead Sciences

Verification Date

December 2011

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

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