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Study of PEG-rIL-29 (or PEG-IFN Lambda) in Subjects With Chronic Hepatitis C Virus Infection

This study has been completed.
Sponsor:
Information provided by:
ZymoGenetics
ClinicalTrials.gov Identifier:
NCT00565539
First received: November 29, 2007
Last updated: October 6, 2009
Last verified: October 2009
History of Changes
  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 test the safety and antiviral effects of PEG-rIL-29 (a man-made form of IL-29) when it is given either by itself at different doses or in combination with the approved dose of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease or who have relapsed following previous treatment with PEGylated interferon alpha (PEG-IFN-α), or other form of IFN-α, and ribavirin.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: PEGylated recombinant interleukin 29 (PEG-rIL-29)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Assess the Safety and Antiviral Activity of PEG-rIL-29 Administered as a Single Agent and in Combination With Ribavirin in Treatment-Relapsed and Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ZymoGenetics:

Primary Outcome Measures:
  • Adverse events and standard clinical laboratory abnormalities [ Time Frame: Day 59 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HCV RNA levels, serum concentrations of PEG-rIL-29, serum beta2-microglobulin (B2M) levels, serum 2'5' oligoadenylate synthetase (OAS) levels, the presence of anti-PEG-rIL-29 antibodies [ Time Frame: Day 59 ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: December 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: PEGylated recombinant interleukin 29 (PEG-rIL-29)
    subcutaneous administration either weekly or every other week
    Other Name: PEGylated interferon lambda (PEG-IFN lambda)
Detailed Description:

This is a 3-part study of PEG-rIL-29 in subjects with chronic genotype 1 hepatitis C virus infection who have either received no prior treatment with a PEGylated IFN-α (or other form of IFN-α) or who have relapsed following prior treatment with a PEGylated IFN-α (or other form of IFN-α) and ribavirin. Part 1 of the study will evaluate the safety and tolerability of escalating doses of PEG-rIL-29 when given as a single agent either every other week or weekly over a 4-week period to treatment-relapsed subjects. Part 2 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin administered over a 4-week period to treatment-relapsed subjects. Part 3 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin administered over a 4-week period to subjects who have received no prior treatment.

  Eligibility

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

Inclusion Criteria:

  • Relapsed subjects (Parts 1 and 2) -- Prior treatment for HCV with PEG-IFN-alpha (or other IFN-alpha) and ribavirin for at least 12 weeks. Naive subjects (Part 3) -- No prior treatment with PEG-IFN-alpha (or other IFN-alpha)
  • Genotype 1 HCV RNA greater than or equal to 100,000 IU/mL. Mixed genotype HCV infection is not allowed
  • Documented liver biopsy ≤2 years of study enrollment with Ishak score ≤4
  • No evidence of hepatocellular carcinoma documented by abdominal imaging within 12 months of study entry
  • no evidence of clinically significant diastolic or systolic dysfunction or other clinically significant abnormalities on echocardiogram or ECG
  • Negative drug and alcohol tests except for physician prescribed or approved medication
  • If male, or female of child-bearing potential, agrees to use 2 forms of medically accepted contraception while on study

Exclusion Criteria:

  • Evidence of decompensated liver disease
  • History of hypersensitivity to IFN-alpha or ribavirin
  • Active substance abuse, such as alcohol, inhaled or injection drugs within the previous 6 months
  • Undergone surgery or received blood products within 30 days prior to study enrollment
  • Prior history of cardiomyopathy, coronary artery disease including angina, interventive procedure for coronary artery disease including angioplasty, stent procedure or cardiac bypass surgery, prior myocardial infarction, or ventricular tachycardia
  • Prior or current history of hemoglobinopathy or hemolytic anemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565539

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
University Hospital (UMDNJ)
Newark, New Jersey, United States, 07103
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine
Houston, Texas, United States, 77030
St. Luke's Advanced Liver Therapies
Houston, Texas, United States, 77030
Alamo Medical Research
San Antonio, Texas, United States, 77030
United States, Virginia
VCUHS Hepatology Research Division
Richmond, Virginia, United States, 23249
Canada, Ontario
London Health Sciences Center
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
ZymoGenetics
Investigators
Study Director: Diana F Hausman, MD ZymoGenetics
  More Information

No publications provided

Responsible Party: Sherri Souza, Clinical Trial Manager, ZymoGenetics
ClinicalTrials.gov Identifier: NCT00565539     History of Changes
Other Study ID Numbers: 526F06
Study First Received: November 29, 2007
Last Updated: October 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ZymoGenetics:
PEGylated recombinant interleukin 29
interferon lambda
interleukin 29
hepatitis C
 virus
infection
liver

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
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 19, 2013