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

Sponsored by:	ZymoGenetics
Information provided by:	ZymoGenetics
ClinicalTrials.gov Identifier:	NCT00565539

Purpose

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 relapsed hepatitis C infection following previous treatment with PEGylated interferon alpha (PEG-IFN-α), or other form of IFN-α, and ribavirin.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: PEGylated recombinant interleukin 29 (PEG-rIL-29)	Phase I

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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 Subjects With Treatment-Relapsed Chronic Hepatitis C Virus Infection

Further study details as provided by ZymoGenetics:

Primary Outcome Measures:

Adverse events and standard clinical laboratory abnormalities [ Time Frame: Day 59 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: Day 59 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	December 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

subcutaneous administration either weekly or every other week

Detailed Description:

This is a 2-part study of PEG-rIL-29 in subjects with chronic genotype 1 hepatitis C virus infection 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. Part 2 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 selected from Part 1 in combination with daily oral ribavirin administered over a 4-week period.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prior treatment for HCV with PEG-IFN-alpha and ribavirin
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565539

Contacts

Contact: Sherri Souza

(206) 434-4702

seso@zgi.com

Locations

United States, Illinois
Northwestern Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60611
Contact: Kim Sipich 312-503-0121 k-sipich@northwestern.edu
Principal Investigator: Steven L Flamm, MD
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Stephanie Johnson 507-284-9709 johnson.stephanie@mayo.edu
Principal Investigator: Russell Wiesner, MD
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27705
Contact: Catee Mullen, PA-C 919-681-9479 catee.mullen@duke.edu
Principal Investigator: Andrew Muir, MD
United States, Oregon
Oregon Health Sciences University	Recruiting
Portland, Oregon, United States, 97239
Contact: Suni Wilson 503-494-5392 wilsons@ohsu.edu
Contact: Margaret Dean 503-418-8332 deanma@ohsu.edu
Principal Investigator: Atif Zaman, MD
United States, Texas
Alamo Medical Research	Recruiting
San Antonio, Texas, United States, 77030
Contact: Ray Hernandez 210-253-3426 rhernandez@alamomedicalresearch.com
Principal Investigator: Eric Lawitz, MD
Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Ketevan Garza-Gasitashvilli 713-791-1414 ext 5619 garzagas@bcm.tmc.edu
Contact: Vladimir Khaoustov 713-791-1414 ext 5619 adimirk@bcm.tmc.edu
Principal Investigator: Boris Yoffe, MD
St. Luke's Advanced Liver Therapies	Recruiting
Houston, Texas, United States, 77030
Contact: Jana Lee 832-355-8708 jlee@sleh.com
Principal Investigator: John Vierling, MD
United States, Virginia
VCUHS Hepatology Research Division	Recruiting
Richmond, Virginia, United States, 23249
Contact: J. Marshall Jamerson, RN, BSN 804-675-6517 JudithJamerson@va.gov
Principal Investigator: Mitchell Shiffman, MD

Sponsors and Collaborators

ZymoGenetics

Investigators

Study Director:

Diana F Hausman, MD

ZymoGenetics

More Information

Responsible Party:	ZymoGenetics ( Sherri Souza, Senior Clinical Research Associate )
Study ID Numbers:	526F06
Study First Received:	November 29, 2007
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00565539
Health Authority:	United States: Food and Drug Administration

Keywords provided by ZymoGenetics:

PEGylated recombinant interleukin 29
interferon lambda
interleukin 29
hepatitis C

virus
infection
liver

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents

Therapeutic Uses
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009