Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

March 4, 2014 updated by: Gilead Sciences

A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection

This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
527

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australia, 2137
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia, 2217
        • St. George Hospital
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Gallipoli MRF
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital Research Foundation
      • Woollongabba, Queensland, Australia, 4102
        • Princess Alexandria
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) Gastrointestinal Research Institute
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network-Toronto Western Hospital
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates, Inc.
  • Italy
      • San Giovanni Rotondo, Italy, 71013
        • Casa Sollievo della Sofferenza Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academish Medisch Centrum
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand
        • Auckland City Hospital
    • BOP
      • Tauranga, BOP, New Zealand, 3143
        • Tauranga Hospital
    • Canterbury
      • Chrischurch, Canterbury, New Zealand, 8001
        • Christchurch Hospital
    • OTA
      • Dunedin, OTA, New Zealand, 9010
        • Mercy Hospital
    • WGN
      • Newtown, WGN, New Zealand, 6021
        • Wellington Hospital
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Waikato Hospital (District Health Board)
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
  • Sweden
      • Göteborg, Sweden, 41685
        • Sahlgrenska Universitetssjukhuset, Östra Sjukhus
      • Stockholm, Sweden, 171 76
        • Karolinska Universitetssjukhuset, Solna
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Montgomery, Alabama, United States, 36116
        • Alabama Liver & Digestive Specialist
    • California
      • Bakersfield, California, United States, 93301
        • Franco Felizarta, MD
      • Beverly Hills, California, United States, 90210
        • California Liver Institute
      • Colton, California, United States, 92324
        • Arrowhead Regional Medical Center
      • Coronado, California, United States, 92118
        • Scti Research Foundation
      • La Mesa, California, United States, 91940
        • eStudy Site
      • Los Angeles, California, United States, 90036
        • Peter J. Ruane, M.D. Inc.
      • Oceanside, California, United States, 92056
        • eStudySite
      • Sacramento, California, United States, 95817
        • University of California, Davis - Health System
      • San Diego, California, United States, 92105
        • Research and Education, Inc.
      • San Diego, California, United States, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, United States, 92103
        • University of California San Diego Medical Center
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • Colorado
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology, PC
    • Florida
      • Bradenton, Florida, United States, 34209
        • Pointe West Infectious Diseases
      • Fort Pierce, Florida, United States, 34982
        • Midway Immunology & Research Center, LLC
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Medicine
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic Baptist
      • Miami, Florida, United States, 33136
        • University of Miami, School of Medicine
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • Orlando, Florida, United States, 32806
        • Internal Medicine Specialists
      • Trinity, Florida, United States, 34655
        • Advanced Research Institute
      • Wellington, Florida, United States, 33414
        • South Florida Center of Gastroenterology
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Gastroenterology Associates
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta, Inc.
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology Research Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Digestive Disease Associates, P.A.
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Springfield, Massachusetts, United States, 01105
        • The Research Institute
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts, Worcester
      • Worcester, Massachusetts, United States, 01608-1320
        • Partners in Internal Medicine, PC
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Digestive Health Specialists, PA
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • Veterans Affairs Medical Center
      • Egg Harbor Township, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC
      • Hillsborough, New Jersey, United States, 08844
        • ID Care
      • Morristown, New Jersey, United States, 07960
        • Atlantic Research Affiliates, LLC
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Southwest C.A.R.E. Center
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • Rochester, New York, United States, 14662
        • University of Rochester
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, P.A.
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Statesville, North Carolina, United States, 28677
        • Carolinas Center For Liver Disease
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Gastroenterology United of Tulsa
    • Oregon
      • Medford, Oregon, United States, 97504
        • Schleinitz Research and Gastroenterology LLC
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Regional Gastroenterology Associates of Lancaster, Ltd.
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Center for Liver Diseases
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • University Gastroenterology
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37211
        • Nashville Gastrointestinal Specialists Inc.
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • Research Specialists of Texas
      • Houston, Texas, United States, 77030
        • VAMC & Baylor College
      • Houston, Texas, United States, 77005
        • Kelsey-Seybold Clinic PA
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialist, Ltd.
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic Genotype 2 or 3 HCV-infection
  • Naive to all HCV antiviral treatment(s)

Exclusion Criteria:

  • Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
  • History of any other clinically significant chronic liver disease
  • A history consistent with decompensated liver disease
  • History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
  • Participation in a clinical study within 3 months prior to first dose

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sofosbuvir+RBV
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi™
Drug: RBV

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose

  • Dose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg
  • Dose of PEG+RBV group: 800 mg
Active Comparator: PEG+RBV
Participants were randomized to receive PEG+RBV for 24 weeks.
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Other Names:
  • Pegasys®
Drug: RBV

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose

  • Dose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg
  • Dose of PEG+RBV group: 800 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
Time Frame: Post-treatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.
Post-treatment Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time Frame: Up to 12 Weeks
Up to 12 Weeks
Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Time Frame: Up to 24 weeks plus 30 days following the last dose of study drug
Up to 24 weeks plus 30 days following the last dose of study drug
Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)
Time Frame: Post-treatment Week 24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.
Post-treatment Week 24
Change From Baseline in HCV RNA
Time Frame: Baseline to Week 12
Baseline to Week 12
Percentage of Participants With Virologic Failure During Treatment
Time Frame: Baseline up to Week 24

Virologic failure was defined as either

  • Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement
  • Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement
  • Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)
Baseline up to Week 24
Percentage of Participants With Viral Relapse Following Treatment
Time Frame: Up to Post-treatment Week 24
Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.
Up to Post-treatment Week 24

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P7977-1231

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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