Overview

This trial is active, not recruiting.

Condition hepatitis c, chronic
Treatments peg-ril-29, peginterferon alfa-2a, ribavirin
Phase phase 2
Sponsor ZymoGenetics
Collaborator Bristol-Myers Squibb
Start date May 2010
End date November 2010
Trial size 600 participants
Trial identifier NCT01001754, 2009-011786-80, 526H04

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 evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
peg-ril-29
Weekly SC injections in combination with ribavirin for up to 48 weeks
ribavirin
Daily oral administration (400-600 mg BID)
(Experimental)
peg-ril-29
Weekly SC injections in combination with ribavirin for up to 48 weeks
ribavirin
Daily oral administration (400-600 mg BID)
(Active Comparator)
peginterferon alfa-2a PEGASYS
Weekly SC injections in combination with ribavirin for up to 48 weeks
ribavirin
Daily oral administration (400-600 mg BID)

Primary Outcomes

Measure
HCV RNA
time frame: At week 12, week 24, or week 48
Incidence and severity of adverse events
time frame: Through week 12, week 40, or week 48

Secondary Outcomes

Measure
Incidence and severity of adverse events and laboratory abnormalities
time frame: Up to week 72
HCV RNA
time frame: Up to week 72
PD biomarkers
time frame: Up to week 72
Quality of life assessments
time frame: Up to week 72
Serum drug concentration profile
time frame: Up to week 48

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - No prior therapy for chronic HCV, other than up to 2 weeks of single-agent therapy with a direct-acting antiviral agent, including but not limited to, a protease or polymerase inhibitor - HCV genotype 1, 2, 3, or 4 - HCV RNA ≥100,000 IU/mL - ALT and AST ≤5.0 × ULN - Documented absence of cirrhosis - Able to comprehend the investigational nature of this study and sign an informed consent form Exclusion Criteria: - Mixed genotype HCV infection - Current or prior history of decompensated liver disease - Received any investigational drug, including a direct-acting antiviral agent, within 60 days prior to receiving study drug - Positive test for hepatitis B surface antigen, human immunodeficiency virus (HIV)-1, or HIV2 antibody at screening - Active substance abuse, such as alcohol, or inhaled or injected drugs, within 6 months Additional inclusion and exclusion criteria are specified in the protocol.

Additional Information

Official title Randomized, Controlled Phase 2a/b Study of the Efficacy and Safety of PEG-rIL-29 Administered in Combination With Ribavirin to Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection
Description PEG-rIL-29 (also known as PEG-interferon lambda) is a unique Type III interferon molecule that has demonstrated antiviral activity when administered weekly for 4 weeks to treatment-relapsed and treatment-naive subjects with genotype 1 hepatitis C virus (HCV) infection. Because PEG-rIL-29 binds to a unique receptor with a more limited distribution than the receptor for interferon (IFN)-α, it may have the potential to treat HCV without some of the treatment-limiting side effects associated with IFN-α-based therapies. The purpose of this Phase 2a/b randomized, controlled, multicenter study is to compare the safety and efficacy of PEG-rIL-29 and peginterferon alfa-2a, both administered subcutaneously weekly for up to 48 weeks in combination with daily oral ribavirin, in treatment-naive subjects with chronic genotype 1, 2, 3, or 4 HCV infection. The initial part of the study (Phase 2a) will be conducted as an open-label study; the second part of the study (Phase 2b) will be conducted as a blinded study. The above information provided in this listing is specific to the Phase 2b portion of the study. In addition, two small open-label substudies will be conducted to evaluate the efficacy of 24-week treatment with PEG-rIL-29 and ribavirin in subjects with HCV genotype 1 who have a particular genetic polymorphism associated with favorable response (n=60) and to evaluate the efficacy of 16-week treatment with PEG-rIL-29 and ribavirin in subjects with HCV genotype 2 or 3 (n=30).
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by ZymoGenetics.