Clinical trial NCT01353248: GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
Official title: A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C
HCV
Rapid Virologic Response
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
HCV RNA
Polymerase inhibitor
Protease inhibitor
Treatment naïve
GS-5885
GS-9451
Tegobuvir
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-05-13
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.


Eligibility criteria: Inclusion Criteria:

* Adult subjects 18 to 70 years of age
* Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
* Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
* Monoinfection with HCV genotype 1a or 1b
* HCV treatment-naïve
* Body mass index (BMI) between 18 and 36 kg/m2
* Creatinine clearance ≥ 50 mL/min
* Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
* Screening laboratory values within defined thresholds

Exclusion Criteria:

* Autoimmune disease
* Decompensated liver disease or cirrhosis
* Poorly controlled diabetes mellitus
* Severe psychiatric illness
* Severe chronic obstructive pulmonary disease (COPD)
* Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
* Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
* History of hemoglobinopathy
* Known retinal disease
* Subjects who are immunosuppressed
* Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
* Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening

Primary outcomes:
measure: Sustained virologic response (SVR)
timeFrame: 24 weeks of off-treatment follow-up
Secondary outcomes:
measure: Safety and tolerability
timeFrame: through 24 weeks of off-treatment follow-up
measure: HCV RNA < Lower Limit Of Quantification
timeFrame: Weeks 1, 2, 4, 12 and 24
measure: Rescue Therapy Substudy SVR
timeFrame: 24 Weeks
measure: Emergence of viral resistance
timeFrame: 12 or 24 weeks
measure: Viral dynamics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV
timeFrame: Through Week 2 of therapy
measure: Pharmacokinetics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV
timeFrame: Through Week 2 of therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Gastroenterology Associates, P.C.
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Coronado
country: United States
facility: Southern California Liver Centers
state: California
city: Fresno
country: United States
facility: UCSF Fresno Medical Education Program (MEP)
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Bradenton
country: United States
facility: Bach and Godofsky Infectious Diseases
state: Florida
city: Gainesville
country: United States
facility: University of Florida - Gainesville
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia PC
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Opelousas
country: United States
facility: Private Practice
state: Louisiana
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
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: Jackson
country: United States
facility: Gastrointestinal Associates, PA
state: Mississippi
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Nashville
country: United States
facility: Columbia Medical Group, The Frist Clinic
state: Tennessee
city: Nashville
country: United States
facility: Nashville Gastrointestinal Specialists, Inc
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research, LC
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Hospital - Center for Liver Diseases
state: Virginia
city: Newport News
country: United States
facility: Liver Institute of Virginia, Bon Secours Health System
state: Virginia
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Gilead Sciences
name: Benedetta Massetto, MD, PhD
role: STUDY_DIRECTOR
References: