Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
NEUTRINO
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
1 other identifier
interventional
328
2 countries
56
Brief Summary
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2012
Shorter than P25 for phase_3
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 9, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
May 8, 2014
CompletedMay 8, 2014
April 1, 2014
7 months
July 9, 2012
February 25, 2014
April 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Sustained Virologic Response (SVR)12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
Posttreatment Week 12
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.
Baseline to Week 12
Secondary Outcomes (4)
Percentage of Participants Achieving SVR4
Posttreatment Week 4
Percentage of Participants Achieving SVR24
Posttreatment Week 24
Percentage of Participants With Viral Breakthrough
Baseline to Week 12
Percentage of Participants With Viral Relapse
End of treatment to post-treatment Week 24
Study Arms (1)
Sofosbuvir+PEG+RBV
EXPERIMENTALInterventions
Sofosbuvir 400 mg tablet administered orally once daily
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Eligibility Criteria
You may qualify if:
- Infection with HCV genotype 1, 4, 5, or 6
- Cirrhosis determination
- Subject met the following classifications:
- Treatment-naive
- Screening laboratory values within defined thresholds
- Not treated with any investigational drug or device within 30 days of screening
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
You may not qualify if:
- Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
- Pregnant or nursing female, or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- History of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (56)
University of Alabama Birmingham
Birmingham, Alabama, 35294-2170, United States
SCTI Research Foundation
Coronado, California, 92118, United States
Kaiser Permanente
Los Angeles, California, 90027, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036, United States
Anthony Mills MD, Inc.
Los Angeles, California, 90069, United States
University of California San Diego
San Diego, California, 92103, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
Kaiser Permanente
San Diego, California, 92154, United States
Quest Clinical Research
San Francisco, California, 94115, United States
University of Colorado
Aurora, Colorado, 80045, United States
South Denver Gastroenterology, PC
Englewood, Colorado, 80113, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009, United States
Capital Medical Associates
Washington D.C., District of Columbia, 20036, United States
University of Florida
Gainesville, Florida, 32610-0277, United States
Borland-Groover Clinic Baptist
Jacksonville, Florida, 32256, United States
University of Miami Center for Liver Diseases
Miami, Florida, 33136, United States
Advanced Research Institute
New Port Richey, Florida, 34653, United States
Orlando Immunology Center (ACH)
Orlando, Florida, 32803-1851, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
South Florida Center of Gastroenterology, P.A.
Wellington, Florida, 33414, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Infectious Disease Specialist of Atlanta
Decatur, Georgia, 30033, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
Johns Hopkins University
Lutherville, Maryland, 21093, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
The Research Institute
Springfield, Massachusetts, 01105, United States
Henry Ford Health System
Novi, Michigan, 48377, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, 55114, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
ID Care
Hillsborough, New Jersey, 08844, United States
Southwest C.A.R.E. Center
Santa Fe, New Mexico, 87505, United States
Binghamton Gastroenterology Associates
Binghamton, New York, 13903, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Gastro One
Germantown, Tennessee, 38138, United States
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, 37211, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, 75219, United States
Research Specialists of Texas
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, 22042, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, 23226, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Fundacion De Investigacion De Diego
San Juan, PR, 00927, Puerto Rico
Related Publications (3)
Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.
PMID: 23607594RESULTYounossi ZM, Stepanova M, Henry L, Gane E, Jacobson IM, Lawitz E, Nelson D, Gerber L, Nader F, Hunt S. Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1349-59.e13. doi: 10.1016/j.cgh.2013.11.032. Epub 2013 Dec 6.
PMID: 24316172RESULTStepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.
PMID: 25040192DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2012
First Posted
July 17, 2012
Study Start
June 1, 2012
Primary Completion
January 1, 2013
Study Completion
April 1, 2013
Last Updated
May 8, 2014
Results First Posted
May 8, 2014
Record last verified: 2014-04