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)

April 8, 2014 updated by: Gilead Sciences

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2170
        • University of Alabama Birmingham
    • California
      • Coronado, California, United States, 92118
        • Scti Research Foundation
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente
      • Los Angeles, California, United States, 90036
        • Peter J. Ruane, MD, Inc.
      • Los Angeles, California, United States, 90069
        • Anthony Mills MD, Inc.
      • San Diego, California, United States, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, United States, 92103
        • University of California San Diego
      • San Diego, California, United States, 92154
        • Kaiser Permanente
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology, PC
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Whitman Walker Clinic
      • Washington, District of Columbia, United States, 20036
        • Capital Medical Associates
    • Florida
      • Gainesville, Florida, United States, 32610-0277
        • University of Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic Baptist
      • Miami, Florida, United States, 33136
        • University of Miami Center for Liver Diseases
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute
      • Orlando, Florida, United States, 32806
        • Internal Medicine Specialists
      • Orlando, Florida, United States, 32803-1851
        • Orlando Immunology Center (ACH)
      • Wellington, Florida, United States, 33414
        • South Florida Center of Gastroenterology, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
      • Decatur, Georgia, United States, 30033
        • Infectious Disease Specialist of Atlanta
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology Research Foundation
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves-Gilbert Clinic
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates, LLC
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Springfield, Massachusetts, United States, 01105
        • The Research Institute
    • Michigan
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
    • Minnesota
      • St. Paul, Minnesota, United States, 55114
        • Minnesota Gastroenterology, P.A.
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Gastroenterology and Hepatology
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
      • Hillsborough, New Jersey, United States, 08844
        • ID Care
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Southwest C.A.R.E. Center
    • New York
      • Binghamton, New York, United States, 13903
        • Binghamton Gastroenterology Associates
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, P.A.
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37211
        • Nashville Gastrointestinal Specialists, Inc
    • Texas
      • Dallas, Texas, United States, 75219
        • Southwest Infectious Disease Clinical Research, Inc.
      • Houston, Texas, United States, 77030
        • Research Specialists of Texas
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital Center for Liver Diseases
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, United States, 23226
        • Bon Secours St. Mary's Hospital of Richmond, Inc.
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sofosbuvir+PEG+RBV
Drug: RBV
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)
Other Names:
  • Ribasphere®
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Other Names:
  • PEGASYS®
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Sustained Virologic Response (SVR)12
Time Frame: Posttreatment Week 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
Time Frame: Baseline to Week 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving SVR4
Time Frame: Posttreatment Week 4
SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
Posttreatment Week 4
Percentage of Participants Achieving SVR24
Time Frame: Posttreatment Week 24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
Posttreatment Week 24
Percentage of Participants With Viral Breakthrough
Time Frame: Baseline to Week 12
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.
Baseline to Week 12
Percentage of Participants With Viral Relapse
Time Frame: End of treatment to post-treatment Week 24
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.
End of treatment to post-treatment Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-0110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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