Status:
UNKNOWN
Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection
Lead Sponsor:
ZymoGenetics
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 evaluate the safety and antiviral effects of several different doses ...
Detailed 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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01001754
Start Date
May 1 2010
End Date
May 1 2012
Last Update
December 5 2011
Active Locations (79)
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1
Beverly Hills, California, United States
2
Coronado, California, United States, 92118
3
La Jolla, California, United States
4
Palm Springs, California, United States, 92262