Hepatitis C, ChronicPhase 2EMERGENCT01001754
Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection
A Phase 2 study testing PEG-rIL-29, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by ZymoGenetics at 79 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- PEG-rIL-29, Peginterferon alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 79 sitesin 11 countries
- Study dates
- May 2010to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
79 sites in 11 countries.
79 sites in 11 countries
United States29 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Arlington, Texas, 76012
Study site
Atlanta, Georgia, 30308
Study site
Aurora, Colorado, 80045
Study site
Beverly Hills, California
Study site
Charlotte, North Carolina, 28207
Study site
Coronado, California, 92118
Study site
Detroit, Michigan, 48202
Study site
Durham, North Carolina, 27710
Study site
Englewood, Colorado, 80113
Study site
Fairfax, Virginia, 22031
Study site
Gainesville, Florida, 32610
Study site
Houston, Texas, 77030
Study site
La Jolla, California
Study site
Lutherville, Maryland, 21093
Study site
Manhasset, New York, 11030
Study site
Miami, Florida
Study site
New York, New York, 10021
Study site
Newark, New Jersey
Study site
Newport News, Virginia
Study site
Palm Springs, California, 92262
Study site
Philadelphia, Pennsylvania
Study site
Rochester, Minnesota
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78215
Study site
San Francisco, California, 94115
Study site
Seattle, Washington, 98101
Study site
St Louis, Missouri, 63104
Study site
Statesville, North Carolina, 28677
Australia13 sites
Study site
Adelaide
Study site
Camperdown
Study site
Clayton
Study site
Fitzroy
Study site
Fremantle
Study site
Greenslopes
Study site
Herston, Queensland
Study site
Herston
Study site
Kogarah
Study site
Melbourne
Study site
Penrith
Study site
Perth
Study site
Westmead
Germany13 sites
Study site
Bochum
Study site
Cologne
Study site
Düsseldorf
Study site
Essen
Study site
Frankfurt am Main
Study site
Freiburg im Breisgau
Study site
Göttingen
Study site
Hamburg
Study site
Hanover
Study site
Heidelberg
Study site
Mainz
Study site
München
Study site
Tübingen
Poland5 sites
Study site
Bialystok
Study site
Krakow
Study site
Łańcut
Study site
Racibórz
Study site
Wroclaw
Spain5 sites
Study site
Barcelona
Study site
Madrid
Study site
Majadahonda
Study site
Seville
Study site
Valencia
Austria4 sites
Study site
Graz
Study site
Innsbruck
Study site
Linz
Study site
Vienna
Canada3 sites
Study site
London, Ontario
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
About this study
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
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.
Read the 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 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).
- Conditions
- Hepatitis C, Chronic
- Being tested
- PEG-rIL-29, Peginterferon alfa-2a, Ribavirin
- Keywords
- Hepatitis C, Hepatitis C, Chronic, PEGylated recombinant interleukin 29, PEG-interferon lambda, Interleukin 29, Virus, Infection, Liver Diseases
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Virus Diseases, Infections, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rIL-29Drug
Weekly SC injections in combination with ribavirin for up to 48 weeks
Peginterferon alfa-2aDrug
Also called PEGASYS
Weekly SC injections in combination with ribavirin for up to 48 weeks
RibavirinDrug
Daily oral administration (400-600 mg BID)
| Study group | Role | What they receive |
|---|---|---|
| PEG-rIL-29 at 120 µg | Experimental | Not described Receives: Drug: PEG-rIL-29; Drug: Ribavirin |
| PEG-rIL-29 at 180 µg | Experimental | Not described Receives: Drug: PEG-rIL-29; Drug: Ribavirin |
| Peginterferon alfa-2a at 180 µg | Active comparator | Not described Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA
Measured: At week 12, week 24, or week 48
Incidence and severity of adverse events
Measured: Through week 12, week 40, or week 48
Secondary outcomes (5)
Incidence and severity of adverse events and laboratory abnormalities
Measured: Up to week 72
HCV RNA
Measured: Up to week 72
PD biomarkers
Measured: Up to week 72
Quality of life assessments
Measured: Up to week 72
Serum drug concentration profile
Measured: Up to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZymoGenetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Jan Hillson, MD, Study director, ZymoGenetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001754
- Sponsor's protocol ID
- 526H04
- Other IDs
- 2009-011786-80, 2009
- Acronym
- EMERGE
- Status last verified
- Dec 2011
- First submitted
- 23 Oct 2009
- Last updated
- 5 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25043197Hruska 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.
PubMed 25042797
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01001754
- Acronym / sponsor ID
- EMERGE / 526H04
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, Hepatitis C, Chronic, PEGylated recombinant interleukin 29, PEG-interferon lambda, Interleukin 29, Virus, Infection, Liver Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- ZymoGeneticsIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEG-rIL-29 at 120 µg | Experimental | Drug: PEG-rIL-29, Drug: Ribavirin |
| PEG-rIL-29 at 180 µg | Experimental | Drug: PEG-rIL-29, Drug: Ribavirin |
| Peginterferon alfa-2a at 180 µg | Active comparator | Drug: Peginterferon alfa-2a, Drug: Ribavirin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-rIL-29Weekly SC injections in combination with ribavirin for up to 48 weeks | Drug | PEG-rIL-29 at 120 µg, PEG-rIL-29 at 180 µg |
| Peginterferon alfa-2aAlso: PEGASYSWeekly SC injections in combination with ribavirin for up to 48 weeks | Drug | Peginterferon alfa-2a at 180 µg |
| RibavirinDaily oral administration (400-600 mg BID) | Drug | PEG-rIL-29 at 120 µg, PEG-rIL-29 at 180 µg, Peginterferon alfa-2a at 180 µg |
Primary outcome
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
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2011.
- Derived from this study: PubMed 25043197Wang 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.
- Derived from this study: PubMed 25042797Hruska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Hillson, MD study director
ZymoGenetics
79 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-rIL-29, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by ZymoGenetics at 79 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Australia, Germany, Poland, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV RNA (time frame: At week 12, week 24, or week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01001754, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2011.