Text Size

PSI-7977 With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6 (ATOMIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01329978
First received: March 30, 2011
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to assess the safety, tolerability, and efficacy of PSI-7977 administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: PSI-7977 with PEG/RBV
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: Yes ]
    To assess the safety of PSI-7977 in combination with PEG/RBV for 12 or 24 weeks of treatment

  • Efficacy of PSI-7977 in subjects treated for 12 or 24 weeks [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]
    To assess the efficacy of PSI-7977 with PEG/RBV for 12 or 24 weeks of treatment as measured by HCV RNA levels of detection.


Secondary Outcome Measures:
  • Change in circulating HCV ribonucleic acid (RNA) [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]
    To assess the change in circulating HCV RNA in patients over 12 or 24 weeks of dosing.

  • Number of participants with Sustained Viral Response (SVR) post-treatment [ Time Frame: Week 12 or Week 24 ] [ Designated as safety issue: No ]
    To assess the SVR at Week 12 or Week 24 after treatment.


Enrollment: 332
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 Weeks PSI-7977 with PEG/RBV
12 weeks of PSI-7977 in combination with PEG/RBV
 Drug: PSI-7977 with PEG/RBV
PSI-7977 with PEG/RBV 12 weeks, PSI-7977 with PEG/RBV 24 weeks PSI-7977 with RBV, PSI-7977 monotherapy
Other Names:
  • PSI-7977
  • PEG/RBV
  • Pegylated Interferon
  • Ribavirin
  • Pegylated Interferon alfa-2a
Experimental: 24 Weeks PSI-7977 with PEG/RBV
24 weeks of PSI-7977 in combination with PEG/RBV
 Drug: PSI-7977 with PEG/RBV
PSI-7977 with PEG/RBV 12 weeks, PSI-7977 with PEG/RBV 24 weeks PSI-7977 with RBV, PSI-7977 monotherapy
Other Names:
  • PSI-7977
  • PEG/RBV
  • Pegylated Interferon
  • Ribavirin
  • Pegylated Interferon alfa-2a
Experimental: PSI-7977 with PEG/RBV
12 Weeks of PSI-7977 in combination with PEG/RBV; subjects are re-randomized at Week 12 to either PSI-7977 monotherapy or PSI-7977 with RBV
 Drug: PSI-7977 with PEG/RBV
PSI-7977 with PEG/RBV 12 weeks, PSI-7977 with PEG/RBV 24 weeks PSI-7977 with RBV, PSI-7977 monotherapy
Other Names:
  • PSI-7977
  • PEG/RBV
  • Pegylated Interferon
  • Ribavirin
  • Pegylated Interferon alfa-2a

  Eligibility

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

Inclusion Criteria:

  • Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
  • Naive to previous HCV treatment

Exclusion Criteria:

  • Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
  • History of any other clinically significant chronic liver disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329978

  Show 46 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Bob Hindes Gilead Sciences
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01329978     History of Changes
Other Study ID Numbers: P7977-0724
Study First Received: March 30, 2011
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis C
HCV
Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
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

ClinicalTrials.gov processed this record on June 18, 2013