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GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection (NEUTRINO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01641640
First received: July 9, 2012
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

GS7977 in combination with ribavirin (RBV) and Peginterferon Alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with Hepatitis C (HCV) genotypes 1, 4, 5 , or 6 (GT-1, GT-4, GT-5, or GT-6) as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR)12.


Condition Intervention Phase
Chronic Hepatitis C
 Drug: GS 7977 in combination with PEG and RBV
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Chronic Genotype 1, 4, 5, or 6 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: 12 weeks ] [ Designated as safety issue: No ]
    The proportion of patients with a sustained virologic response (SVR) 12 weeks after the end of treatment

  • The safety and tolerability of GS-7977+RBV+PEG when given for 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The safety and tolerability of GS-7977+PEG+RBV as assessed by review of the accumulated safety data


Secondary Outcome Measures:
  • Efficacy 4 and 24 weeks post dosing [ Time Frame: 4 weeks and 24 weeks ] [ Designated as safety issue: No ]
    To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)

  • Amount of circulating HCV RNA [ Time Frame: 12 weeks post dosing ] [ Designated as safety issue: No ]
    To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation

  • Characterization of viral resistance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the emergence of viral resistance to GS 7977 during treatment and after treatment discontinuation


Enrollment: 328
Study Start Date: June 2012
Estimated Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-7977 and Peginterferon Alfa 2 and Ribavirin
GS-7977 (400 mg QD) + PEG (180 μg/week) + RBV (1000 or 1200 mg/day)
 Drug: GS 7977 in combination with PEG and RBV
GS 7977 400 mg QD + PEG 180 μg/week +RBV BID
Other Names:
  • GS-7977
  • RBV
  • Ribavirin
  • PEG
  • Peginterferon Alfa 2a

  Eligibility

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

Inclusion Criteria:

  • Infection with HCV GT 1, 4, 5, or 6
  • Cirrhosis determination
  • Subject meets the following classifications:Treatment-Naïve
  • Screening laboratory values within defined thresholds
  • Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Prior exposure to an direct-acting antiviral targeting the HCV NS5B polymerase
  • Pregnant or nursing female or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641640

  Show 56 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: NCT01641640     History of Changes
Other Study ID Numbers: GS-US-334-0110
Study First Received: July 9, 2012
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HCV genotype 1 (GT-1)
HCV genotype 4 (GT-4)
HCV genotype 5 (GT-5)
HCV genotype 6 (GT-6)
HCV
Sustained Virologic Response
Direct Acting Antiviral
 Combination Therapy
Treatment-Naïve
GS-7977
Ribavirin
RBV
Peginterferon Alfa 2a
PEG

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

ClinicalTrials.gov processed this record on May 19, 2013