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Hepatitis CPhase 3FISSIONNCT01497366

Phase 3 Study of Sofosbuvir and Ribavirin

A Phase 3 study testing Sofosbuvir, PEG and RBV in people with Hepatitis C, run by Gilead Sciences at 97 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
Sofosbuvir, PEG and RBV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
527 participants
Where
97 sitesin 8 countries
Study dates
Dec 2011to Apr 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

97 sites in 8 countries.

97 sites in 8 countries

United States67 sites

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • AIDS Research Consortium of Atlanta, Inc.

    Atlanta, Georgia, 30308

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • Franco Felizarta, MD

    Bakersfield, California, 93301

  • Digestive Disease Associates, P.A.

    Baltimore, Maryland, 21229

  • California Liver Institute

    Beverly Hills, California, 90210

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Pointe West Infectious Diseases

    Bradenton, Florida, 34209

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Arrowhead Regional Medical Center

    Colton, California, 92324

  • SCTI Research Foundation

    Coronado, California, 92118

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Veterans Affairs Medical Center

    East Orange, New Jersey, 07018

  • AGA Clinical Research Associates, LLC

    Egg Harbor, New Jersey, 08234

  • South Denver Gastroenterology, PC

    Englewood, Colorado, 80113

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • Midway Immunology & Research Center, LLC

    Ft. Pierce, Florida, 34982

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • Gastro One

    Germantown, Tennessee, 38138

  • ID Care

    Hillsborough, New Jersey, 08844

  • Kelsey-Seybold Clinic PA

    Houston, Texas, 77005

  • Research Specialists of Texas

    Houston, Texas, 77030

  • VAMC & Baylor College

    Houston, Texas, 77030

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237

  • Borland-Groover Clinic Baptist

    Jacksonville, Florida, 32256

  • eStudy Site

    La Mesa, California, 91940

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Lancaster, Pennsylvania, 17604

  • Peter J. Ruane, M.D. Inc.

    Los Angeles, California, 90036

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Schleinitz Research and Gastroenterology LLC

    Medford, Oregon, 97504

  • University of Miami, School of Medicine

    Miami, Florida, 33136

  • Alabama Liver & Digestive Specialist

    Montgomery, Alabama, 36116

  • Atlantic Research Affiliates, LLC

    Morristown, New Jersey, 07960

  • Nashville Gastrointestinal Specialists Inc.

    Nashville, Tennessee, 37211

  • Weill Cornell Medical College

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Digestive and Liver Disease Specialist, Ltd.

    Norfolk, Virginia, 23502

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • eStudySite

    Oceanside, California, 92056

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • UPMC Center For Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • University of Rochester

    Rochester, New York, 14662

  • University of California, Davis - Health System

    Sacramento, California, 95817

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • University of California San Diego Medical Center

    San Diego, California, 92103

  • Research and Education, Inc.

    San Diego, California, 92105

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • Quest Clinical Research

    San Francisco, California, 94115

  • Southwest C.A.R.E. Center

    Santa Fe, New Mexico, 87505

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • The Research Institute

    Springfield, Massachusetts, 01105

  • Carolinas Center for Liver Disease

    Statesville, North Carolina, 28677

  • Advanced Research Institute

    Trinity, Florida, 34655

  • Gastroenterology United of Tulsa

    Tulsa, Oklahoma, 74135

  • Digestive Health Specialists, PA

    Tupelo, Mississippi, 38801

  • University Gastroenterology

    Warwick, Rhode Island, 02886

  • South Florida Center of Gastroenterology

    Wellington, Florida, 33414

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

  • Partners in Internal Medicine, PC

    Worcester, Massachusetts, 01608-1320

  • University of Massachusetts, Worcester

    Worcester, Massachusetts, 01655

Other trials in United States

Australia14 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2137

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Gallipoli MRF

    Greenslopes, Queensland, 4120

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Brisbane Hospital Research Foundation

    Herston, Queensland, 4029

  • St. George Hospital

    Kogarah, New South Wales, 2217

  • The Alfred

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner

    Nedlands, Western Australia, 6009

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Princess Alexandria

    Woollongabba, Queensland, 4102

Other trials in Australia

New Zealand6 sites

  • Christchurch Hospital

    Chrischurch, Canterbury, 8001

  • Mercy Hospital

    Dunedin, OTA, 9010

  • Auckland City Hospital

    Grafton, Auckland

  • Waikato Hospital (District Health Board)

    Hamilton, Waikato Region, 3240

  • Wellington Hospital

    Newtown, WGN, 6021

  • Tauranga Hospital

    Tauranga, BOP, 3143

Other trials in New Zealand

Canada5 sites

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • University Health Network-Toronto Western Hospital

    Toronto, Ontario, M5G 2N2

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • (G.I.R.I.) Gastrointestinal Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Associates, Inc.

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset, Östra Sjukhus

    Gothenburg, 41685

  • Karolinska Universitetssjukhuset, Solna

    Stockholm, 171 76

Other trials in Sweden

Italy1 site

  • Casa Sollievo della Sofferenza Hospital

    San Giovanni Rotondo, 71013

Other trials in Italy

Netherlands1 site

  • Academish Medisch Centrum

    Amsterdam, 1105 AZ

Other trials in Netherlands

Puerto Rico1 site

  • Fundacion de Investigacion de Diego

    San Juan, Puerto Rico, 00927

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Hepatitis C
Being tested
Sofosbuvir, PEG, RBV
Keywords
HCV genotype 2 (GT-2), HCV genotype 3 (GT-3)
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SofosbuvirDrug

    Also called Sovaldi™, GS-7977, PSI-7977

    Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily

  • PEGDrug

    Also called Pegasys®

    Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

  • RBVDrug

    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
Study groups in NCT01497366
Study groupRoleWhat they receive
Sofosbuvir+RBVExperimentalParticipants were randomized to receive sofosbuvir+RBV for 12 weeks.
Receives: Drug: Sofosbuvir; Drug: RBV
PEG+RBVActive comparatorParticipants were randomized to receive PEG+RBV for 24 weeks.
Receives: Drug: PEG; Drug: RBV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.

    Measured: Post-treatment Week 12

Secondary outcomes (6)

  1. Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities

    Measured: Up to 24 weeks plus 30 days following the last dose of study drug

  2. Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)

    SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.

    Measured: Post-treatment Week 24

  3. Percentage of Participants With HCV RNA < LLOQ on Treatment

    Measured: Up to 12 Weeks

  4. Change From Baseline in HCV RNA

    Measured: Baseline to Week 12

  5. Percentage of Participants With Virologic Failure During Treatment

    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)

    Measured: Baseline up to Week 24

  6. Percentage of Participants With Viral Relapse Following Treatment

    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.

    Measured: Up to Post-treatment Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionJan 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
527 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01497366
Sponsor's protocol ID
P7977-1231
Acronym
FISSION
Status last verified
Mar 2014
First submitted
19 Dec 2011
Last updated
2 Apr 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25040192

  • 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.

    PubMed 23607594

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sofosbuvir, PEG and RBV in people with Hepatitis C, run by Gilead Sciences at 97 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Australia, New Zealand, Canada, Sweden and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (time frame: Post-treatment Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01497366, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.

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