Clinical trial NCT00565539: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C, Chronic
Keywords: PEGylated recombinant interleukin 29
interferon lambda
interleukin 29
hepatitis C
virus
infection
liver
Lead sponsor: ZymoGenetics
Sponsor class: INDUSTRY
First posted: 2007-11-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adverse events and standard clinical laboratory abnormalities
timeFrame: Day 59
Secondary outcomes:
measure: 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
timeFrame: Day 59
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Newark
country: United States
facility: University Hospital (UMDNJ)
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Houston
country: United States
facility: Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: St. Luke's Advanced Liver Therapies
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Richmond
country: United States
facility: VCUHS Hepatology Research Division
state: Virginia
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
Study officials:
affiliation: ZymoGenetics
name: Diana F Hausman, MD
role: STUDY_DIRECTOR
References: