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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ZymoGenetics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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