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

Sponsor:	ZymoGenetics
Collaborator:	Bristol-Myers Squibb
Information provided by (Responsible Party):	ZymoGenetics
ClinicalTrials.gov Identifier:	NCT01001754

Purpose

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C Liver Diseases

Drug Information available for: Ribavirin Peginterferon Alfa-2a Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by ZymoGenetics:

Primary Outcome Measures:

HCV RNA [ Time Frame: At week 12, week 24, or week 48 ] [ Designated as safety issue: No ]
Incidence and severity of adverse events [ Time Frame: Through week 12, week 40, or week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence and severity of adverse events and laboratory abnormalities [ Time Frame: Up to week 72 ] [ Designated as safety issue: Yes ]
HCV RNA [ Time Frame: Up to week 72 ] [ Designated as safety issue: No ]
PD biomarkers [ Time Frame: Up to week 72 ] [ Designated as safety issue: No ]
Quality of life assessments [ Time Frame: Up to week 72 ] [ Designated as safety issue: No ]
Serum drug concentration profile [ Time Frame: Up to week 48 ] [ Designated as safety issue: No ]

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).

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001754

Show 79 Study Locations

Sponsors and Collaborators

ZymoGenetics

Bristol-Myers Squibb

Investigators

Study Director:

Jan Hillson, MD

ZymoGenetics

More Information

No publications provided

Responsible Party:	ZymoGenetics
ClinicalTrials.gov Identifier:	NCT01001754 History of Changes
Other Study ID Numbers:	526H04, 2009-011786-80
Study First Received:	October 23, 2009
Last Updated:	December 2, 2011
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada

Keywords provided by ZymoGenetics:

Hepatitis C
Hepatitis C, Chronic
PEGylated recombinant interleukin 29
PEG-interferon lambda

Interleukin 29
Virus
Infection
Liver Diseases

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
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 February 08, 2012