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
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Study Type | Interventional |
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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 |
Enrollment | 527 |
Participant Flow
Recruitment Details | 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 | 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. |
Arm/Group Title | Sofosbuvir+RBV | PEG+RBV |
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Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks. | Participants were randomized to receive PEG+RBV for 24 weeks. |
Period Title: Overall Study | ||
Started | 263 | 264 |
Randomized But Not Treated | 7 | 21 |
Completed | 224 | 176 |
Not Completed | 39 | 88 |
Reason Not Completed | ||
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
Arm/Group Title | Sofosbuvir+RBV | PEG+RBV | Total | |
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Participants were randomized to receive sofosbuvir+RBV for 12 weeks. | Participants were randomized to receive PEG+RBV for 24 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 256 | 243 | 499 | |
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Safety Analysis Set
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 256 participants | 243 participants | 499 participants | |
48 (10.8) | 48 (11.4) | 48 (11.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 256 participants | 243 participants | 499 participants | |
Female |
85 33.2%
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87 35.8%
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172 34.5%
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Male |
171 66.8%
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156 64.2%
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327 65.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 256 participants | 243 participants | 499 participants | |
Hispanic or Latino |
41 16.0%
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31 12.8%
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72 14.4%
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Not Hispanic or Latino |
215 84.0%
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212 87.2%
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427 85.6%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 256 participants | 243 participants | 499 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
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 256 participants | 243 participants | 499 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
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 256 participants | 243 participants | 499 participants |
Genotype 1 | 3 | 0 | 3 | |
Genotype 2 | 70 | 67 | 137 | |
Genotype 3 | 183 | 176 | 359 | |
Baseline HCV RNA
Mean (Standard Deviation) Unit of measure: Log10 IU/mL |
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Number Analyzed | 256 participants | 243 participants | 499 participants | |
6.0 (0.82) | 6.0 (0.78) | 6.0 (0.80) | ||
Baseline HCV RNA Category
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 256 participants | 243 participants | 499 participants |
< 6 log10 IU/mL | 108 | 106 | 214 | |
≥ 6 log10 IU/mL | 148 | 137 | 285 | |
IL28b genotype
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 256 participants | 243 participants | 499 participants |
CC | 108 | 106 | 214 | |
CT | 121 | 98 | 219 | |
TT | 25 | 38 | 63 | |
Missing | 2 | 1 | 3 | |
Cirrhosis
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 256 participants | 243 participants | 499 participants |
No | 205 | 189 | 394 | |
Yes | 50 | 50 | 100 | |
Missing | 1 | 4 | 5 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
- The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
- The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: | Clinical Trial Disclosures |
Organization: | Gilead Sciences, Inc. |
EMail: | ClinicalTrialDisclosures@gilead.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01497366 |
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 |