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

NCT ID: NCT01001754

Last Updated: 2011-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Hepatitis C, Chronic

Keywords

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Hepatitis C Hepatitis C, Chronic PEGylated recombinant interleukin 29 PEG-interferon lambda Interleukin 29 Virus Infection Liver Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PEG-rIL-29 at 120 µg

Group Type EXPERIMENTAL

PEG-rIL-29

Intervention Type DRUG

Weekly SC injections in combination with ribavirin for up to 48 weeks

Ribavirin

Intervention Type DRUG

Daily oral administration (400-600 mg BID)

PEG-rIL-29 at 180 µg

Group Type EXPERIMENTAL

PEG-rIL-29

Intervention Type DRUG

Weekly SC injections in combination with ribavirin for up to 48 weeks

Ribavirin

Intervention Type DRUG

Daily oral administration (400-600 mg BID)

Peginterferon alfa-2a at 180 µg

Group Type ACTIVE_COMPARATOR

Peginterferon alfa-2a

Intervention Type DRUG

Weekly SC injections in combination with ribavirin for up to 48 weeks

Ribavirin

Intervention Type DRUG

Daily oral administration (400-600 mg BID)

Interventions

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PEG-rIL-29

Weekly SC injections in combination with ribavirin for up to 48 weeks

Intervention Type DRUG

Peginterferon alfa-2a

Weekly SC injections in combination with ribavirin for up to 48 weeks

Intervention Type DRUG

Ribavirin

Daily oral administration (400-600 mg BID)

Intervention Type DRUG

Other Intervention Names

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PEGASYS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

ZymoGenetics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Hillson, MD

Role: STUDY_DIRECTOR

ZymoGenetics

Locations

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Beverly Hills, California, United States

Site Status

Coronado, California, United States

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La Jolla, California, United States

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Palm Springs, California, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Englewood, Colorado, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Lutherville, Maryland, United States

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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Newark, New Jersey, United States

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Albuquerque, New Mexico, United States

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Manhasset, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Statesville, North Carolina, United States

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Philadelphia, Pennsylvania, United States

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Arlington, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Fairfax, Virginia, United States

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Newport News, Virginia, United States

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Seattle, Washington, United States

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Herston, Queensland, Australia

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Adelaide, , Australia

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Camperdown, , Australia

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Clayton, , Australia

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Fitzroy, , Australia

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Fremantle, , Australia

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Greenslopes, , Australia

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Herston, , Australia

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Kogarah, , Australia

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Melbourne, , Australia

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Penrith, , Australia

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Perth, , Australia

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Westmead, , Australia

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Graz, , Austria

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Innsbruck, , Austria

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Linz, , Austria

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Vienna, , Austria

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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Paris, , France

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Pessac, , France

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Bochum, , Germany

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Cologne, , Germany

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Düsseldorf, , Germany

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Essen, , Germany

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Frankfurt am Main, , Germany

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Freiburg im Breisgau, , Germany

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Göttingen, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Mainz, , Germany

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München, , Germany

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Tübingen, , Germany

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Milan, , Italy

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Bialystok, , Poland

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Krakow, , Poland

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Racibórz, , Poland

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Wroclaw, , Poland

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Łańcut, , Poland

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Santurce, , Puerto Rico

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Bucharest, , Romania

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Iași, , Romania

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Timișoara, , Romania

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Barcelona, , Spain

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Madrid, , Spain

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Majadahonda, , Spain

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Seville, , Spain

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Valencia, , Spain

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Countries

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United States Australia Austria Canada France Germany Italy Poland Puerto Rico Romania Spain

References

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Wang X, Hruska M, Chan P, Ahmad A, Freeman J, Horga MA, Hillson J, Kansra V, Lopez-Talavera JC. Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 1: Modeling optimal treatment duration and sustained virologic response rates. J Clin Pharmacol. 2015 Jan;55(1):63-72. doi: 10.1002/jcph.363. Epub 2014 Jul 24.

Reference Type DERIVED
PMID: 25043197 (View on PubMed)

Hruska M, Wang X, Chan P, Ahmad A, Freeman J, Horga MA, Hillson J, Kansra V, Lopez-Talavera JC. Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 2: Exposure-response analyses for efficacy and safety variables. J Clin Pharmacol. 2015 Jan;55(1):73-80. doi: 10.1002/jcph.361. Epub 2014 Jul 24.

Reference Type DERIVED
PMID: 25042797 (View on PubMed)

Other Identifiers

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2009-011786-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

526H04

Identifier Type: -

Identifier Source: org_study_id