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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PEGylated recombinant interleukin 29 (PEG-rIL-29)
Sponsored by
ZymoGenetics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring PEGylated recombinant interleukin 29, interferon lambda, interleukin 29, hepatitis C, virus, infection, liver

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Memorial Hospital
  • Henry Ford Health System
  • Mayo Clinic
  • University Hospital (UMDNJ)
  • Duke University Medical Center
  • Oregon Health Sciences University
  • Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine
  • St. Luke's Advanced Liver Therapies
  • Alamo Medical Research
  • VCUHS Hepatology Research Division
  • London Health Sciences Center

Outcomes

Primary Outcome Measures

Adverse events and standard clinical laboratory abnormalities

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

Full Information

First Posted
November 29, 2007
Last Updated
October 6, 2009
Sponsor
ZymoGenetics
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1. Study Identification

Unique Protocol Identification Number
NCT00565539
Brief Title
Study of PEG-rIL-29 (or PEG-IFN Lambda) in Subjects With Chronic Hepatitis C Virus Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ZymoGenetics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
PEGylated recombinant interleukin 29, interferon lambda, interleukin 29, hepatitis C, virus, infection, liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PEGylated recombinant interleukin 29 (PEG-rIL-29)
Other Intervention Name(s)
PEGylated interferon lambda (PEG-IFN lambda)
Intervention Description
subcutaneous administration either weekly or every other week
Primary Outcome Measure Information:
Title
Adverse events and standard clinical laboratory abnormalities
Time Frame
Day 59
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana F Hausman, MD
Organizational Affiliation
ZymoGenetics
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University Hospital (UMDNJ)
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's Advanced Liver Therapies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
VCUHS Hepatology Research Division
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

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

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