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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by ZymoGenetics.
Recruitment status was:  Active, not recruiting
Bristol-Myers Squibb
Information provided by (Responsible Party):
ZymoGenetics Identifier:
First received: October 23, 2009
Last updated: December 2, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Hepatitis C, Chronic Drug: PEG-rIL-29 Drug: Peginterferon alfa-2a Drug: Ribavirin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by ZymoGenetics:

Primary Outcome Measures:
  • HCV RNA [ Time Frame: At week 12, week 24, or week 48 ]
  • Incidence and severity of adverse events [ Time Frame: Through week 12, week 40, or week 48 ]

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

Estimated Enrollment: 600
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Peginterferon alfa-2a
Weekly SC injections in combination with ribavirin for up to 48 weeks
Other Name: PEGASYS
Drug: Ribavirin
Daily oral administration (400-600 mg BID)

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).

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01001754

  Show 79 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Jan Hillson, MD ZymoGenetics
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ZymoGenetics Identifier: NCT01001754     History of Changes
Other Study ID Numbers: 526H04
2009-011786-80 ( EudraCT Number )
Study First Received: October 23, 2009
Last Updated: December 2, 2011

Keywords provided by ZymoGenetics:
Hepatitis C
Hepatitis C, Chronic
PEGylated recombinant interleukin 29
PEG-interferon lambda
Interleukin 29
Liver Diseases

Additional relevant MeSH terms:
Hepatitis C, Chronic
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 20, 2017