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Phase 3 Study of PSI-7977 and Ribavirin (FISSION)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01497366
First received: December 19, 2011
Last updated: February 20, 2013
Last verified: January 2013
History of Changes
  Purpose

PSI-7977 in combination with ribavirin (RBV) administered for 12 weeks is safe and superior to Pegylated Interferon/ Ribavirin (PEG/RBV) administered for 24 weeks in treatment-naïve patients with Hepatitis C (HCV) genotype 2 or 3 (GT-2 or GT-3) as assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).


Condition Intervention Phase
Hepatitis C
 Drug: PSI-7977 in combination with ribavirin
Drug: Pegylated interferon in combination with ribavirin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 529
Study Start Date: December 2011
Estimated Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PSI-7977 and ribavirin
12 weeks of PSI-7977 400mg QD in combination with ribavirin
 Drug: PSI-7977 in combination with ribavirin
PSI-7977 400mg QD for 12 weeks in combination with ribavirin
Active Comparator: Pegylated interferon and ribavirin
pegylated interferon, with ribavirin 800mg QD
 Drug: Pegylated interferon in combination with ribavirin
Pegasys® (as directed) RBV 800 mg QD
Other Names:
  • PEG
  • pegylated interferon alfa-2a
  • ribavirin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Positive test at Screening for HBsAg, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497366

  Show 97 Study Locations
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional 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
Study First Received: December 19, 2011
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
 Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013