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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565539
• Other study ID #: 526F06
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2007
• Last updated: October 6, 2009
• Start date: December 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: ZymoGenetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Virus Diseases

Intervention

Drug:
• PEGylated recombinant interleukin 29 (PEG-rIL-29)
subcutaneous administration either weekly or every other week

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine	Houston	Texas
United States	St. Luke's Advanced Liver Therapies	Houston	Texas
United States	University Hospital (UMDNJ)	Newark	New Jersey
United States	Oregon Health Sciences University	Portland	Oregon
United States	VCUHS Hepatology Research Division	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Alamo Medical Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ZymoGenetics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and standard clinical laboratory abnormalities		Day 59	Yes
Secondary	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	No