search
Back to results

Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

Primary Purpose

Hepatitis C

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

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring HCV genotype 2 (GT-2), HCV genotype 3 (GT-3)

Eligibility Criteria

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

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

Sites / Locations

  • University of Alabama at Birmingham
  • Alabama Liver & Digestive Specialist
  • Franco Felizarta, MD
  • California Liver Institute
  • Arrowhead Regional Medical Center
  • SCTI Research Foundation
  • eStudy Site
  • Peter J. Ruane, M.D. Inc.
  • eStudySite
  • University of California, Davis - Health System
  • University of California San Diego Medical Center
  • Research and Education, Inc.
  • Medical Associates Research Group, Inc.
  • Quest Clinical Research
  • South Denver Gastroenterology, PC
  • Pointe West Infectious Diseases
  • Midway Immunology & Research Center, LLC
  • University of Florida College of Medicine
  • Borland-Groover Clinic Baptist
  • University of Miami, School of Medicine
  • Orlando Immunology Center
  • Internal Medicine Specialists
  • Advanced Research Institute
  • South Florida Center of Gastroenterology
  • AIDS Research Consortium of Atlanta, Inc.
  • Atlanta Gastroenterology Associates
  • Gastrointestinal Specialists of Georgia, PC
  • University of Chicago
  • Indianapolis Gastroenterology Research Foundation
  • Digestive Disease Associates, P.A.
  • Beth Israel Deaconess Medical Center
  • The Research Institute
  • Partners in Internal Medicine, PC
  • University of Massachusetts, Worcester
  • Henry Ford Health System
  • Digestive Health Specialists, PA
  • Veterans Affairs Medical Center
  • AGA Clinical Research Associates, LLC
  • ID Care
  • Atlantic Research Affiliates, LLC
  • Southwest C.A.R.E. Center
  • North Shore University Hospital
  • Weill Cornell Medical College
  • Mount Sinai School of Medicine
  • University of Rochester
  • Asheville Gastroenterology Associates, P.A.
  • Duke University Medical Center
  • Carolinas Center for Liver Disease
  • Digestive Health Specialists, PA
  • University of Cincinnati
  • Gastroenterology United of Tulsa
  • Schleinitz Research and Gastroenterology LLC
  • Regional Gastroenterology Associates of Lancaster, Ltd.
  • UPMC Center For Liver Diseases
  • University Gastroenterology
  • Gastro One
  • Nashville Gastrointestinal Specialists Inc.
  • Texas Clinical Research Institute, LLC
  • Baylor University Medical Center
  • Kelsey-Seybold Clinic PA
  • Research Specialists of Texas
  • VAMC & Baylor College
  • Alamo Medical Research
  • Metropolitan Research
  • Digestive and Liver Disease Specialist, Ltd.
  • Digestive and Liver Disease Specialists
  • Virginia Mason Medical Center
  • Canberra Hospital
  • Royal Prince Alfred Hospital
  • Concord Repatriation General Hospital
  • St. George Hospital
  • Gallipoli MRF
  • Royal Brisbane Hospital Research Foundation
  • Princess Alexandria
  • Royal Adelaide Hospital
  • Monash Medical Centre
  • Austin Hospital
  • The Alfred
  • Fremantle Hospital
  • Sir Charles Gairdner
  • Royal Perth Hospital
  • (G.I.R.I.) Gastrointestinal Research Institute
  • Mount Sinai Hospital
  • University Health Network-Toronto Western Hospital
  • Toronto Liver Centre
  • Toronto Digestive Disease Associates, Inc.
  • Casa Sollievo della Sofferenza Hospital
  • Academish Medisch Centrum
  • Auckland City Hospital
  • Tauranga Hospital
  • Christchurch Hospital
  • Mercy Hospital
  • Waikato Hospital (District Health Board)
  • Wellington Hospital
  • Fundacion de Investigacion de Diego
  • Sahlgrenska Universitetssjukhuset, Östra Sjukhus
  • Karolinska Universitetssjukhuset, Solna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sofosbuvir+RBV

PEG+RBV

Arm Description

Participants were randomized to receive sofosbuvir+RBV for 12 weeks.

Participants were randomized to receive PEG+RBV for 24 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
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.
Percentage of Participants With HCV RNA < LLOQ on Treatment
Change From Baseline in HCV RNA
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)
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.

Full Information

First Posted
December 19, 2011
Last Updated
March 4, 2014
Sponsor
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01497366
Brief Title
Phase 3 Study of Sofosbuvir and Ribavirin
Acronym
FISSION
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
HCV genotype 2 (GT-2), HCV genotype 3 (GT-3)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
527 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sofosbuvir+RBV
Arm Type
Experimental
Arm Description
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
Arm Title
PEG+RBV
Arm Type
Active Comparator
Arm Description
Participants were randomized to receive PEG+RBV for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Sovaldi™, GS-7977, PSI-7977
Intervention Description
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
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
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.
Time Frame
Post-treatment Week 12
Secondary Outcome Measure Information:
Title
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
Title
Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)
Description
SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.
Time Frame
Post-treatment Week 24
Title
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time Frame
Up to 12 Weeks
Title
Change From Baseline in HCV RNA
Time Frame
Baseline to Week 12
Title
Percentage of Participants With Virologic Failure During Treatment
Description
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)
Time Frame
Baseline up to Week 24
Title
Percentage of Participants With Viral Relapse Following Treatment
Description
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.
Time Frame
Up to Post-treatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Alabama Liver & Digestive Specialist
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Franco Felizarta, MD
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
California Liver Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Arrowhead Regional Medical Center
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
SCTI Research Foundation
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
eStudy Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91940
Country
United States
Facility Name
Peter J. Ruane, M.D. Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
eStudySite
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
University of California, Davis - Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Research and Education, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92105
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
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
South Denver Gastroenterology, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Pointe West Infectious Diseases
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Midway Immunology & Research Center, LLC
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
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, School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Advanced Research Institute
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
South Florida Center of Gastroenterology
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
AIDS Research Consortium of Atlanta, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Digestive Disease Associates, P.A.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
The Research Institute
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
Country
United States
Facility Name
Partners in Internal Medicine, PC
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608-1320
Country
United States
Facility Name
University of Massachusetts, Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Veterans Affairs Medical Center
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
AGA Clinical Research Associates, LLC
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
ID Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Atlantic Research Affiliates, LLC
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
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
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
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
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14662
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
Carolinas Center for Liver Disease
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
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
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Gastroenterology United of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Schleinitz Research and Gastroenterology LLC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Regional Gastroenterology Associates of Lancaster, Ltd.
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
UPMC Center For Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University Gastroenterology
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
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
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Kelsey-Seybold Clinic PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Research Specialists of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
VAMC & Baylor College
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
Digestive and Liver Disease Specialist, Ltd.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2137
Country
Australia
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Gallipoli MRF
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Royal Brisbane Hospital Research Foundation
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandria
City
Woollongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Sir Charles Gairdner
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
(G.I.R.I.) Gastrointestinal Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
University Health Network-Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Toronto Digestive Disease Associates, Inc.
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Casa Sollievo della Sofferenza Hospital
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Academish Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Auckland
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
State/Province
BOP
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Christchurch Hospital
City
Chrischurch
State/Province
Canterbury
ZIP/Postal Code
8001
Country
New Zealand
Facility Name
Mercy Hospital
City
Dunedin
State/Province
OTA
ZIP/Postal Code
9010
Country
New Zealand
Facility Name
Waikato Hospital (District Health Board)
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
State/Province
WGN
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Sahlgrenska Universitetssjukhuset, Östra Sjukhus
City
Göteborg
ZIP/Postal Code
41685
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset, Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Citations:
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
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
derived

Learn more about this trial

Phase 3 Study of Sofosbuvir and Ribavirin

We'll reach out to this number within 24 hrs