Clinical trial NCT01591668: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Hepatitis
Hepatitis C
Chronic HCV
HCV
Treatment Naive
Gilead
GS-9620
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 51
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 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.


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

Primary outcomes:
measure: Incidence of adverse events in single and multiple doses of GS-9620
timeFrame: Periodically Day 1 to 6 months
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: Days 1, 2, 3, 5, 8
measure: Reduction of hepatitis C (HCV) RNA viral load from baseline
timeFrame: Screening, Baseline, Day 8 or 15
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Kansas City
country: United States
facility: Kansas City Gastroenterology and Hepatology
state: Missouri
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: New York
country: United States
facility: CliniLabs
state: New York
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Santurce
country: Puerto Rico
facility: Fundacion De Investigacion De Diego
Study officials:
References:
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.