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

Sponsor

ZymoGenetics (Industry)

Overall Status

Completed

CT.gov ID

NCT00565539

Collaborator

(none)

Enrollment

Locations

Duration (Months)

5.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Outcome Measures

Primary Outcome Measures

Adverse events and standard clinical laboratory abnormalities [Day 59]

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 [Day 59]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
2	Henry Ford Health System	Detroit	Michigan	United States	48202
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	University Hospital (UMDNJ)	Newark	New Jersey	United States	07103
5	Duke University Medical Center	Durham	North Carolina	United States	27705
6	Oregon Health Sciences University	Portland	Oregon	United States	97239
7	Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine	Houston	Texas	United States	77030
8	St. Luke's Advanced Liver Therapies	Houston	Texas	United States	77030
9	Alamo Medical Research	San Antonio	Texas	United States	77030
10	VCUHS Hepatology Research Division	Richmond	Virginia	United States	23249
11	London Health Sciences Center	London	Ontario	Canada	N6A 5A5