Clinical trial NCT01384383: GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
Official title: A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 With Peginterferon Alfa 2a and Ribavirin (RBV) in Treatment-Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
IL28B CC Genotype
Treatment naive
Peginterferon α-2a (PEG)
Genotype 1a/b
GS 9451
GS 5885
Ribavirin (RBV)
HCV NS5A inhibitor
HCV NS3 protease inhibitor
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-06-29
Enrollment: 248
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: This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.


Eligibility criteria: Inclusion Criteria:

* Males and females 18-70 years of age
* Chronic HCV infection
* Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed
* Monoinfection with HCV genotype 1a or 1b
* HCV RNA \> 10\^4 IU/mL at Screening
* IL28B CC genotype
* HCV treatment naïve
* Candidate for PEG/RBV therapy
* Body mass index (BMI) between 18 and 36 kg/m2
* Creatinine clearance \>= 50 mL/min
* Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline

Exclusion Criteria:

* Exceed defined thresholds for key laboratory parameters at Screening
* Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed
* Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study
* Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment

Primary outcomes:
measure: Sustained virologic response (SVR)
timeFrame: 30 , 36 or 48 weeks
Secondary outcomes:
measure: Safety and tolerability of therapy
timeFrame: Up to 48 weeks
measure: Virologic response
timeFrame: Weeks 2, 4, 6, 8, 10, and 12
measure: Compare SVR
timeFrame: Weeks 30 and 36
measure: Viral resistance
timeFrame: Up to 96 Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: V.A. Greater Los Angeles Healthcare System
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Diego
country: United States
facility: Research and Education, Inc.
state: California
city: San Jose
country: United States
facility: San Jose Gastroenterology
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Englewood
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Brockton
country: United States
facility: Commonwealth Clinical Studies, LLC
state: Massachusetts
city: Las Vegas
country: United States
facility: Impact Clinical Trials
state: Nevada
city: Great Neck
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell College of Medicine
state: New York
city: Yonkers
country: United States
facility: Westchester Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, P.A.
state: North Carolina
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Arlington
country: United States
facility: The North Texas Research Institute
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Pediatric Pulmonology
state: Utah
city: Fairfax
country: United States
facility: Metropolitan Liver Diseases Center
state: Virginia
city: Newport News
country: United States
facility: Liver Institute of Virginia, Bon Secours Health System
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: Saint Vincents Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St. George Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane Hospital Research Foundation
state: Queensland
city: Woolloongabba
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital, Sydney Ltd.
state: Victoria
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health, Department of Hepatology
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: LAIR Centre
state: British Columbia
city: Vancouver
country: Canada
facility: GIRI GI Research Institute
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba, John Buhler Research Centre
state: Manitoba
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Aukland
country: New Zealand
facility: Auckland Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
Study officials:
References: