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Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01497366
First received: December 19, 2011
Last updated: March 4, 2014
Last verified: March 2014
History of Changes
Results First Received: January 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: Sofosbuvir
Drug: PEG
Drug: RBV

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled in a total of 90 study sites in the United States, Australia, New Zealand, Canada, Sweden, Italy, and the Netherlands. The first participant was screened on 19 December 2011. The last participant observation was on 08 April 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
666 participants were screened and 527 were randomized; 499 participants received at least 1 dose of study drug, and comprise the Safety Analysis Set. The 496 participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug comprise the Full Analysis Set.

Reporting Groups
  Description
Sofosbuvir+RBV Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks.
PEG+RBV Participants were randomized to receive PEG+RBV for 24 weeks.

Participant Flow:   Overall Study
    Sofosbuvir+RBV     PEG+RBV  
STARTED     263     264  
Randomized But Not Treated     7     21  
COMPLETED     224     176  
NOT COMPLETED     39     88  
Virologic failure                 2                 50  
Lost to Follow-up                 11                 10  
Withdrawal by Subject                 6                 6  
Initiated Non-protocol HCV Treatment                 7                 0  
Unknown                 5                 0  
Death                 1                 1  
Randomized but not treated                 7                 21  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set

Reporting Groups
  Description
Sofosbuvir+RBV Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
PEG+RBV Participants were randomized to receive PEG+RBV for 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Sofosbuvir+RBV     PEG+RBV     Total  
Number of Participants  
[units: participants]
 		  256     243     499  
Age  
[units: years]
Mean ± Standard Deviation 		  48  ± 10.8     48  ± 11.4     48  ± 11.0  
Gender  
[units: participants]
 		     
Female     85     87     172  
Male     171     156     327  
Ethnicity (NIH/OMB)  
[units: participants]
 		     
Hispanic or Latino     41     31     72  
Not Hispanic or Latino     215     212     427  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
 		     
Black or African American     12     5     17  
White     223     212     435  
Asian     14     15     29  
American Indian/Alaska Native/First Nations     4     4     8  
Hawaiian or Pacific Islander     2     6     8  
Black and White     1     0     1  
South American     0     1     1  
Region of Enrollment  
[units: participants]
 		     
United States     165     151     316  
Canada     15     24     39  
Australia     32     29     61  
Netherlands     3     1     4  
Italy     8     4     12  
New Zealand     29     30     59  
Sweden     4     4     8  
Hepatitis C Virus (HCV) genotype  
[units: participants]
 		     
Genotype 1     3     0     3  
Genotype 2     70     67     137  
Genotype 3     183     176     359  
Baseline HCV RNA  
[units: log10 IU/mL]
Mean ± Standard Deviation 		  6.0  ± 0.82     6.0  ± 0.78     6.0  ± 0.80  
Baseline HCV RNA Category  
[units: participants]
 		     
< 6 log10 IU/mL     108     106     214  
≥ 6 log10 IU/mL     148     137     285  
IL28b genotype  
[units: participants]
 		     
CC     108     106     214  
CT     121     98     219  
TT     25     38     63  
Missing     2     1     3  
Cirrhosis  
[units: participants]
 		     
No     205     189     394  
Yes     50     50     100  
Missing     1     4     5  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)   [ Time Frame: Post-treatment Week 12 ]
  Show Outcome Measure 1

2.  Secondary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)   [ Time Frame: Post-treatment Week 24 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With HCV RNA < LLOQ on Treatment   [ Time Frame: Up to 12 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in HCV RNA   [ Time Frame: Baseline to Week 12 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With Virologic Failure During Treatment   [ Time Frame: Baseline up to Week 24 ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants With Viral Relapse Following Treatment   [ Time Frame: Up to Post-treatment Week 24 ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


No publications provided by Gilead Sciences

Publications automatically indexed to this study:


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01497366     History of Changes
Other Study ID Numbers: P7977-1231
Study First Received: December 19, 2011
Results First Received: January 15, 2014
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration