NCT00565539

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2007

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 7, 2009

Status Verified

October 1, 2009

Enrollment Period

1.8 years

First QC Date

November 29, 2007

Last Update Submit

October 6, 2009

Conditions

Hepatitis C, Chronic

Keywords

PEGylated recombinant interleukin 29interferon lambdainterleukin 29hepatitis Cvirusinfectionliver

Outcome Measures

Primary Outcomes (1)

  • Adverse events and standard clinical laboratory abnormalities

    Day 59

Secondary Outcomes (1)

  • 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

    Day 59

Interventions

PEGylated recombinant interleukin 29 (PEG-rIL-29)DRUG

subcutaneous administration either weekly or every other week

Also known as: PEGylated interferon lambda (PEG-IFN lambda)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University Hospital (UMDNJ)

Newark, New Jersey, 07103, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

St. Luke's Advanced Liver Therapies

Houston, Texas, 77030, United States

Location

Alamo Medical Research

San Antonio, Texas, 77030, United States

Location

VCUHS Hepatology Research Division

Richmond, Virginia, 23249, United States

Location

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis CVirus DiseasesInfections

Interventions

peginterferon lambda-1a

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Diana F Hausman, MD

    ZymoGenetics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 29, 2007

First Posted

November 30, 2007

Study Start

December 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 7, 2009

Record last verified: 2009-10

Locations

CA(1)US(10)