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Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT01497366
Ethics application status
Date submitted
19/12/2011
Date registered
21/12/2011
Date last updated
4/03/2014

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) - SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.
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) - SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.
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 - 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)
Timepoint [5] 0 0
Baseline up to Week 24
Secondary outcome [6] 0 0
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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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