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

December 19, 2011
March 4, 2014
December 2011
January 2013   (final data collection date for primary outcome measure)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.
Efficacy 12 weeks post dosing [ Time Frame: SVR 12 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01497366 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) [ Time Frame: Post-treatment Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change From Baseline in HCV RNA [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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.
  • Description of Safety with PSI-7977 and ribavirin [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate the change in circulating HCV RNA in patients over 12 or 24 weeks of dosing
  • ALT normalization [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    To determine the proportion of patients whose ALT normalizes during therapy
  • Number of subjects with virologic failure [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    To describe rates of virologic failure
  • Characterization of drug resistance [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    To characterize HCV drug resistance substitutions at baseline, during, and after therapy with PSI-7977
Not Provided
Not Provided
 
Phase 3 Study of Sofosbuvir and Ribavirin
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
527
April 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Netherlands,   United States,   New Zealand,   Australia,   Italy,   Puerto Rico,   Sweden
 
NCT01497366
P7977-1231
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
March 2014

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