Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection
EMERGE
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
2 other identifiers
interventional
600
10 countries
75
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2010
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedDecember 5, 2011
December 1, 2011
6 months
October 23, 2009
December 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HCV RNA
At week 12, week 24, or week 48
Incidence and severity of adverse events
Through week 12, week 40, or week 48
Secondary Outcomes (5)
Incidence and severity of adverse events and laboratory abnormalities
Up to week 72
HCV RNA
Up to week 72
PD biomarkers
Up to week 72
Quality of life assessments
Up to week 72
Serum drug concentration profile
Up to week 48
Study Arms (3)
PEG-rIL-29 at 120 µg
EXPERIMENTALPEG-rIL-29 at 180 µg
EXPERIMENTALPeginterferon alfa-2a at 180 µg
ACTIVE COMPARATORInterventions
Weekly SC injections in combination with ribavirin for up to 48 weeks
Weekly SC injections in combination with ribavirin for up to 48 weeks
Daily oral administration (400-600 mg BID)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZymoGeneticslead
- Bristol-Myers Squibbcollaborator
Study Sites (79)
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Coronado, California, 92118, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Palm Springs, California, 92262, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Englewood, Colorado, 80113, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Lutherville, Maryland, 21093, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
St Louis, Missouri, 63104, United States
Unknown Facility
Newark, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, 87131, United States
Unknown Facility
Manhasset, New York, 11030, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Charlotte, North Carolina, 28207, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Statesville, North Carolina, 28677, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Arlington, Texas, 76012, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Fairfax, Virginia, 22031, United States
Unknown Facility
Newport News, Virginia, United States
Unknown Facility
Seattle, Washington, 98101, United States
Unknown Facility
Herston, Queensland, Australia
Unknown Facility
Adelaide, Australia
Unknown Facility
Camperdown, Australia
Unknown Facility
Clayton, Australia
Unknown Facility
Fitzroy, Australia
Unknown Facility
Fremantle, Australia
Unknown Facility
Greenslopes, Australia
Unknown Facility
Herston, Australia
Unknown Facility
Kogarah, Australia
Unknown Facility
Melbourne, Australia
Unknown Facility
Penrith, Australia
Unknown Facility
Perth, Australia
Unknown Facility
Westmead, Australia
Unknown Facility
Graz, Austria
Unknown Facility
Innsbruck, Austria
Unknown Facility
Linz, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Paris, France
Unknown Facility
Pessac, France
Unknown Facility
Bochum, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Düsseldorf, Germany
Unknown Facility
Essen, Germany
Unknown Facility
Frankfurt am Main, Germany
Unknown Facility
Freiburg im Breisgau, Germany
Unknown Facility
Göttingen, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Heidelberg, Germany
Unknown Facility
Mainz, Germany
Unknown Facility
München, Germany
Unknown Facility
Tübingen, Germany
Unknown Facility
Milan, Italy
Unknown Facility
Bialystok, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Racibórz, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Łańcut, Poland
Unknown Facility
Santurce, Puerto Rico
Unknown Facility
Bucharest, Romania
Unknown Facility
Iași, Romania
Unknown Facility
Timișoara, Romania
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Majadahonda, Spain
Unknown Facility
Seville, Spain
Unknown Facility
Valencia, Spain
Related Publications (2)
Wang X, Hruska M, Chan P, Ahmad A, Freeman J, Horga MA, Hillson J, Kansra V, Lopez-Talavera JC. Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 1: Modeling optimal treatment duration and sustained virologic response rates. J Clin Pharmacol. 2015 Jan;55(1):63-72. doi: 10.1002/jcph.363. Epub 2014 Jul 24.
PMID: 25043197DERIVEDHruska M, Wang X, Chan P, Ahmad A, Freeman J, Horga MA, Hillson J, Kansra V, Lopez-Talavera JC. Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 2: Exposure-response analyses for efficacy and safety variables. J Clin Pharmacol. 2015 Jan;55(1):73-80. doi: 10.1002/jcph.361. Epub 2014 Jul 24.
PMID: 25042797DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jan Hillson, MD
ZymoGenetics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2009
First Posted
October 27, 2009
Study Start
May 1, 2010
Primary Completion
November 1, 2010
Study Completion
May 1, 2012
Last Updated
December 5, 2011
Record last verified: 2011-12