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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

Tracking Information
First Submitted Date  ICMJE December 19, 2011
First Posted Date  ICMJE December 22, 2011
Results First Submitted Date  ICMJE January 15, 2014
Results First Posted Date  ICMJE April 2, 2014
Last Update Posted Date April 2, 2014
Study Start Date  ICMJE December 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) [ Time Frame: Post-treatment Week 12 ]
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
Efficacy 12 weeks post dosing [ Time Frame: SVR 12 ]
Efficacy of PSI-7977 in combination with RBV administered for 12 weeks compared with PEG/RBV administered for 24 weeks in treatment-naïve patients with HCV genotype 2 or 3 as assessed by the rate of SVR12
Change History Complete list of historical versions of study NCT01497366 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • 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 ]
  • Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) [ Time Frame: Post-treatment Week 24 ]
    SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.
  • Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Up to 12 Weeks ]
  • Change From Baseline in HCV RNA [ Time Frame: Baseline to Week 12 ]
  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Baseline up to Week 24 ]
    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)
  • Percentage of Participants With Viral Relapse Following Treatment [ Time Frame: Up to Post-treatment Week 24 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • Description of Safety with PSI-7977 and ribavirin [ Time Frame: 12 Weeks ]
    Safety and tolerability of PSI-7977/RBV administered for 12 weeks as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to AEs, and Grade 3 or 4 laboratory abnormalities
  • SVR 24 [ Time Frame: 24 Weeks after treatment ]
    To determine the SVR at Week 24 (SVR24) following completion of treatment for each investigational arm
  • Amount of circulating HCV RNA [ Time Frame: 12 or 24 weeks post dosing ]
    To evaluate the change in circulating HCV RNA in patients over 12 or 24 weeks of dosing
  • ALT normalization [ Time Frame: 24 weeks ]
    To determine the proportion of patients whose ALT normalizes during therapy
  • Number of subjects with virologic failure [ Time Frame: 24 Weeks ]
    To describe rates of virologic failure
  • Characterization of drug resistance [ Time Frame: 24 Weeks ]
    To characterize HCV drug resistance substitutions at baseline, during, and after therapy with PSI-7977
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of Sofosbuvir and Ribavirin
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: Sofosbuvir
    Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
    Other Names:
    • Sovaldi™
    • GS-7977
    • PSI-7977
  • Drug: PEG
    Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
    Other Name: Pegasys®
  • Drug: 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
Study Arms  ICMJE
  • Experimental: Sofosbuvir+RBV
    Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
  • Active Comparator: PEG+RBV
    Participants were randomized to receive PEG+RBV for 24 weeks.
    Interventions:
    • Drug: PEG
    • Drug: RBV
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2014)
527
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2011)
500
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic Genotype 2 or 3 HCV-infection
  • Naive to all HCV antiviral treatment(s)

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Italy,   Netherlands,   New Zealand,   Puerto Rico,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01497366
Other Study ID Numbers  ICMJE P7977-1231
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gilead Sciences
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP