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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)

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sofosbuvir
RBV
PEG
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV genotype 1 (GT-1), HCV genotype 4 (GT-4), HCV genotype 5 (GT-5), HCV genotype 6 (GT-6), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Treatment-Naïve, GS-7977, Ribavirin, RBV, Peginterferon Alfa 2a, PEG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Alabama Birmingham
  • SCTI Research Foundation
  • Kaiser Permanente
  • Peter J. Ruane, MD, Inc.
  • Anthony Mills MD, Inc.
  • University of California San Diego
  • Medical Associates Research Group, Inc.
  • Kaiser Permanente
  • Quest Clinical Research
  • University of Colorado
  • South Denver Gastroenterology, PC
  • Whitman Walker Clinic
  • Capital Medical Associates
  • University of Florida
  • Borland-Groover Clinic Baptist
  • University of Miami Center for Liver Diseases
  • Advanced Research Institute
  • Orlando Immunology Center (ACH)
  • Internal Medicine Specialists
  • South Florida Center of Gastroenterology, P.A.
  • Digestive Healthcare of Georgia
  • Infectious Disease Specialist of Atlanta
  • Gastrointestinal Specialists of Georgia, PC
  • Indianapolis Gastroenterology Research Foundation
  • Graves-Gilbert Clinic
  • Gastroenterology Associates, LLC
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • The Research Institute
  • Henry Ford Health System
  • Minnesota Gastroenterology, P.A.
  • Kansas City Gastroenterology and Hepatology
  • Comprehensive Clinical Research
  • ID Care
  • Southwest C.A.R.E. Center
  • Binghamton Gastroenterology Associates
  • Weill Cornell Medical College
  • Mount Sinai School of Medicine
  • Asheville Gastroenterology Associates, P.A.
  • Duke University Medical Center
  • Digestive Health Specialists, PA
  • Hospital of the University of Pennsylvania
  • University Gastroenterology
  • The Miriam Hospital
  • Gastro One
  • Nashville Gastrointestinal Specialists, Inc
  • Southwest Infectious Disease Clinical Research, Inc.
  • Research Specialists of Texas
  • Alamo Medical Research
  • Metropolitan Research
  • Inova Fairfax Hospital Center for Liver Diseases
  • Digestive and Liver Disease Specialists
  • Bon Secours St. Mary's Hospital of Richmond, Inc.
  • Virginia Mason Medical Center
  • Fundacion De Investigacion De Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sofosbuvir+PEG+RBV

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percentage of Participants Achieving SVR4
SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
Percentage of Participants Achieving SVR24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
Percentage of Participants With Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.

Full Information

First Posted
July 9, 2012
Last Updated
April 8, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01641640
Brief Title
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
Acronym
NEUTRINO
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
HCV genotype 1 (GT-1), HCV genotype 4 (GT-4), HCV genotype 5 (GT-5), HCV genotype 6 (GT-6), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Treatment-Naïve, GS-7977, Ribavirin, RBV, Peginterferon Alfa 2a, PEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sofosbuvir+PEG+RBV
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
Sofosbuvir 400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Other Intervention Name(s)
Ribasphere®
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
PEG
Other Intervention Name(s)
PEGASYS®
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Sustained Virologic Response (SVR)12
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
Time Frame
Posttreatment Week 12
Title
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving SVR4
Description
SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
Time Frame
Posttreatment Week 4
Title
Percentage of Participants Achieving SVR24
Description
SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
Time Frame
Posttreatment Week 24
Title
Percentage of Participants With Viral Breakthrough
Description
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
Time Frame
Baseline to Week 12
Title
Percentage of Participants With Viral Relapse
Description
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Time Frame
End of treatment to post-treatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2170
Country
United States
Facility Name
SCTI Research Foundation
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Peter J. Ruane, MD, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Anthony Mills MD, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
South Denver Gastroenterology, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Whitman Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Capital Medical Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0277
Country
United States
Facility Name
Borland-Groover Clinic Baptist
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
University of Miami Center for Liver Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Orlando Immunology Center (ACH)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-1851
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
South Florida Center of Gastroenterology, P.A.
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Digestive Healthcare of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Infectious Disease Specialist of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Graves-Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Johns Hopkins University
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
The Research Institute
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Kansas City Gastroenterology and Hepatology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
ID Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Southwest C.A.R.E. Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Binghamton Gastroenterology Associates
City
Binghamton
State/Province
New York
ZIP/Postal Code
13903
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Asheville Gastroenterology Associates, P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Nashville Gastrointestinal Specialists, Inc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Southwest Infectious Disease Clinical Research, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Research Specialists of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Inova Fairfax Hospital Center for Liver Diseases
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Bon Secours St. Mary's Hospital of Richmond, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Fundacion De Investigacion De Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
23607594
Citation
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.
Results Reference
result
PubMed Identifier
24316172
Citation
Younossi 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.
Results Reference
result
PubMed Identifier
25040192
Citation
Stepanova 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.
Results Reference
derived

Learn more about this trial

Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

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