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Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

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ClinicalTrials.gov Identifier: NCT01497366
Recruitment Status : Completed
First Posted : December 22, 2011
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: Sofosbuvir
Drug: PEG
Drug: RBV

  Participant Flow

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 
Other                5                0 
Death                1                1 
Randomized but not treated                7                21 



  Baseline Characteristics

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 
Overall Participants Analyzed 
[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

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


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01497366     History of Changes
Other Study ID Numbers: P7977-1231
First Submitted: December 19, 2011
First Posted: December 22, 2011
Results First Submitted: January 15, 2014
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014