Clinical trial NCT01590641: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
HBV
Keywords: Hepatitis
Hepatitis B
Hepatitis B Virus
HBV
GS-9620
Toll-like receptor (TLR)-7 Agonist
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-05-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Assessment of adverse events in single and multiple oral doses of GS-9620
timeFrame: Periodically Through Week 25
Secondary outcomes:
measure: Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
timeFrame: Day 1 and Day 8
measure: Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])
timeFrame: Up to Day 15
measure: Reduction of hepatitis B (HBV) viral load from baseline
timeFrame: Up to Day 15 and Follow-Up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Costa Mesa
country: United States
facility: West Coast Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: University of California Antiviral Research Center (AVRC)
state: California
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Gastroenterology and Hepatology
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash University, Department of Medicine
state: Victoria
city: Nedlands
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Calgary
country: Canada
facility: University of Calgary, Heritage Medical Research Center
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Montreal
country: Canada
facility: Algorithme Pharma, Inc.
state: Quebec
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Grafton
country: New Zealand
facility: Auckland Clinical Studies
state: Auckland
Study officials:
affiliation: Gilead Sciences
name: Benedetta Massetto, M.D.
role: STUDY_DIRECTOR
References: