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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01497366




Registration number
NCT01497366
Ethics application status
Date submitted
19/12/2011
Date registered
22/12/2011
Date last updated
2/04/2014

Titles & IDs
Public title
Phase 3 Study of Sofosbuvir and Ribavirin
Scientific 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
Secondary ID [1] 0 0
P7977-1231
Universal Trial Number (UTN)
Trial acronym
FISSION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sofosbuvir
Treatment: Drugs - PEG
Treatment: Drugs - RBV

Experimental: Sofosbuvir+RBV - Participants were randomized to receive sofosbuvir+RBV for 12 weeks.

Active Comparator: PEG+RBV - Participants were randomized to receive PEG+RBV for 24 weeks.


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

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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
Timepoint [1] 0 0
Post-treatment Week 12
Secondary outcome [1] 0 0
Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Timepoint [1] 0 0
Up to 24 weeks plus 30 days following the last dose of study drug
Secondary outcome [2] 0 0
Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)
Timepoint [2] 0 0
Post-treatment Week 24
Secondary outcome [3] 0 0
Percentage of Participants With HCV RNA < LLOQ on Treatment
Timepoint [3] 0 0
Up to 12 Weeks
Secondary outcome [4] 0 0
Change From Baseline in HCV RNA
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
Percentage of Participants With Virologic Failure During Treatment
Timepoint [5] 0 0
Baseline up to Week 24
Secondary outcome [6] 0 0
Percentage of Participants With Viral Relapse Following Treatment
Timepoint [6] 0 0
Up to Post-treatment Week 24

Eligibility
Key inclusion criteria
- Chronic Genotype 2 or 3 HCV-infection

- Naive to all HCV antiviral treatment(s)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
527
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
St. George Hospital - Kogarah
Recruitment hospital [5] 0 0
Gallipoli MRF - Greenslopes
Recruitment hospital [6] 0 0
Royal Brisbane Hospital Research Foundation - Herston
Recruitment hospital [7] 0 0
Princess Alexandria - Woollongabba
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [11] 0 0
The Alfred - Melbourne
Recruitment hospital [12] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [13] 0 0
Sir Charles Gairdner - Nedlands
Recruitment hospital [14] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2137 - Concord
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4102 - Woollongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6160 - Fremantle
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment postcode(s) [14] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Italy
State/province [27] 0 0
San Giovanni Rotondo
Country [28] 0 0
Netherlands
State/province [28] 0 0
Amsterdam
Country [29] 0 0
New Zealand
State/province [29] 0 0
Auckland
Country [30] 0 0
New Zealand
State/province [30] 0 0
BOP
Country [31] 0 0
New Zealand
State/province [31] 0 0
Canterbury
Country [32] 0 0
New Zealand
State/province [32] 0 0
OTA
Country [33] 0 0
New Zealand
State/province [33] 0 0
Waikato
Country [34] 0 0
New Zealand
State/province [34] 0 0
WGN
Country [35] 0 0
Puerto Rico
State/province [35] 0 0
San Juan
Country [36] 0 0
Sweden
State/province [36] 0 0
Göteborg
Country [37] 0 0
Sweden
State/province [37] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01497366
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries