Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection (EMERGE)

December 2, 2011 updated by: ZymoGenetics

Randomized, Controlled Phase 2a/b Study of the Efficacy and Safety of PEG-rIL-29 Administered in Combination With Ribavirin to Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection

Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

PEG-rIL-29 (also known as PEG-interferon lambda) is a unique Type III interferon molecule that has demonstrated antiviral activity when administered weekly for 4 weeks to treatment-relapsed and treatment-naive subjects with genotype 1 hepatitis C virus (HCV) infection. Because PEG-rIL-29 binds to a unique receptor with a more limited distribution than the receptor for interferon (IFN)-α, it may have the potential to treat HCV without some of the treatment-limiting side effects associated with IFN-α-based therapies. The purpose of this Phase 2a/b randomized, controlled, multicenter study is to compare the safety and efficacy of PEG-rIL-29 and peginterferon alfa-2a, both administered subcutaneously weekly for up to 48 weeks in combination with daily oral ribavirin, in treatment-naive subjects with chronic genotype 1, 2, 3, or 4 HCV infection. The initial part of the study (Phase 2a) will be conducted as an open-label study; the second part of the study (Phase 2b) will be conducted as a blinded study. The above information provided in this listing is specific to the Phase 2b portion of the study. In addition, two small open-label substudies will be conducted to evaluate the efficacy of 24-week treatment with PEG-rIL-29 and ribavirin in subjects with HCV genotype 1 who have a particular genetic polymorphism associated with favorable response (n=60) and to evaluate the efficacy of 16-week treatment with PEG-rIL-29 and ribavirin in subjects with HCV genotype 2 or 3 (n=30).

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • Camperdown, Australia
      • Clayton, Australia
      • Fitzroy, Australia
      • Fremantle, Australia
      • Greenslopes, Australia
      • Herston, Australia
      • Kogarah, Australia
      • Melbourne, Australia
      • Penrith, Australia
      • Perth, Australia
      • Westmead, Australia
    • Queensland
      • Herston, Queensland, Australia
  • Austria
      • Graz, Austria
      • Innsbruck, Austria
      • Linz, Austria
      • Wien, Austria
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
  • France
      • Paris, France
      • Pessac, France
  • Germany
      • Bochum, Germany
      • Dusseldorf, Germany
      • Essen, Germany
      • Frankfurt/Main, Germany
      • Freiburg, Germany
      • Goettingen, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Heidelberg, Germany
      • Koln, Germany
      • Mainz, Germany
      • Munchen, Germany
      • Tubingen, Germany
  • Italy
      • Milano, Italy
  • Poland
      • Bialystok, Poland
      • Krakow, Poland
      • Lancut, Poland
      • Raciborz, Poland
      • Wroclaw, Poland
  • Puerto Rico
      • Santurce, Puerto Rico
  • Romania
      • Bucharest, Romania
      • Iasi, Romania
      • Timisoara, Romania
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Majadahonda, Spain
      • Sevilla, Spain
      • Valencia, Spain
  • United States
    • California
      • Beverly Hills, California, United States
      • Coronado, California, United States, 92118
      • La Jolla, California, United States
      • Palm Springs, California, United States, 92262
      • San Francisco, California, United States, 94115
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Englewood, Colorado, United States, 80113
    • Florida
      • Gainesville, Florida, United States, 32610
      • Miami, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
    • Maryland
      • Lutherville, Maryland, United States, 21093
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Rochester, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States, 63104
    • New Jersey
      • Newark, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10021
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
      • Durham, North Carolina, United States, 27710
      • Statesville, North Carolina, United States, 28677
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Arlington, Texas, United States, 76012
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78215
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Virginia
      • Fairfax, Virginia, United States, 22031
      • Newport News, Virginia, United States
    • Washington
      • Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No prior therapy for chronic HCV, other than up to 2 weeks of single-agent therapy with a direct-acting antiviral agent, including but not limited to, a protease or polymerase inhibitor
  • HCV genotype 1, 2, 3, or 4
  • HCV RNA ≥100,000 IU/mL
  • ALT and AST ≤5.0 × ULN
  • Documented absence of cirrhosis
  • Able to comprehend the investigational nature of this study and sign an informed consent form

Exclusion Criteria:

  • Mixed genotype HCV infection
  • Current or prior history of decompensated liver disease
  • Received any investigational drug, including a direct-acting antiviral agent, within 60 days prior to receiving study drug
  • Positive test for hepatitis B surface antigen, human immunodeficiency virus (HIV)-1, or HIV2 antibody at screening
  • Active substance abuse, such as alcohol, or inhaled or injected drugs, within 6 months

Additional inclusion and exclusion criteria are specified in the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEG-rIL-29 at 120 µg
Drug: PEG-rIL-29
Weekly SC injections in combination with ribavirin for up to 48 weeks
Drug: Ribavirin
Daily oral administration (400-600 mg BID)
EXPERIMENTAL: PEG-rIL-29 at 180 µg
Drug: PEG-rIL-29
Weekly SC injections in combination with ribavirin for up to 48 weeks
Drug: Ribavirin
Daily oral administration (400-600 mg BID)
ACTIVE_COMPARATOR: Peginterferon alfa-2a at 180 µg
Drug: Ribavirin
Daily oral administration (400-600 mg BID)
Drug: Peginterferon alfa-2a
Weekly SC injections in combination with ribavirin for up to 48 weeks
Other Names:
  • PEGASYS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HCV RNA
Time Frame: At week 12, week 24, or week 48
At week 12, week 24, or week 48
Incidence and severity of adverse events
Time Frame: Through week 12, week 40, or week 48
Through week 12, week 40, or week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events and laboratory abnormalities
Time Frame: Up to week 72
Up to week 72
HCV RNA
Time Frame: Up to week 72
Up to week 72
PD biomarkers
Time Frame: Up to week 72
Up to week 72
Quality of life assessments
Time Frame: Up to week 72
Up to week 72
Serum drug concentration profile
Time Frame: Up to week 48
Up to week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZymoGenetics

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Jan Hillson, MD, ZymoGenetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

October 23, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (ESTIMATE)

October 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2011

Last Update Submitted That Met QC Criteria

December 2, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 526H04
  • 2009-011786-80 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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