Hepatitis C, ChronicPhase 1NCT00565539
Study of PEG-rIL-29 (or PEG-IFN Lambda) in Subjects With Chronic Hepatitis C Virus Infection
A Phase 1 study testing PEGylated recombinant interleukin 29 (PEG-rIL-29) in people with Hepatitis C, Chronic, run by ZymoGenetics at 11 sites in 2 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 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… 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?
- PEGylated recombinant interleukin 29 (PEG-rIL-29)
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Dec 2007to Oct 2009
- Phase
- Phase 1
- 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
- Relapsed subjects (Parts 1 and 2) -- Prior treatment for HCV with PEG-IFN-alpha (or other IFN-alpha) and ribavirin for at least 12 weeks. Naive subjects (Part 3) -- No prior treatment with PEG-IFN-alpha (or other IFN-alpha)
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27705
Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine
Houston, Texas, 77030
St. Luke's Advanced Liver Therapies
Houston, Texas, 77030
University Hospital (UMDNJ)
Newark, New Jersey, 07103
Oregon Health Sciences University
Portland, Oregon, 97239
VCUHS Hepatology Research Division
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
Alamo Medical Research
San Antonio, Texas, 77030
About this 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 Treatment-Relapsed and 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 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 hepatitis C infection who have received no prior treatment for this disease or who have relapsed following previous treatment with PEGylated interferon alpha (PEG-IFN-α), or other form of IFN-α, and ribavirin.
Read the detailed description
This is a 3-part study of PEG-rIL-29 in subjects with chronic genotype 1 hepatitis C virus infection who have either received no prior treatment with a PEGylated IFN-α (or other form of IFN-α) or 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 to treatment-relapsed subjects. Part 2 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin administered over a 4-week period to treatment-relapsed subjects. Part 3 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin administered over a 4-week period to subjects who have received no prior treatment.
- Conditions
- Hepatitis C, Chronic
- Being tested
- PEGylated recombinant interleukin 29 (PEG-rIL-29)
- Keywords
- PEGylated recombinant interleukin 29, interferon lambda, interleukin 29, hepatitis C, virus, infection, liver
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Virus Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGylated recombinant interleukin 29 (PEG-rIL-29)Drug
Also called PEGylated interferon lambda (PEG-IFN lambda)
subcutaneous administration either weekly or every other week
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and standard clinical laboratory abnormalities
Measured: Day 59
Secondary outcomes (1)
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
Measured: Day 59
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZymoGenetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Diana F Hausman, MD, Study director, ZymoGenetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565539
- Sponsor's protocol ID
- 526F06
- Status last verified
- Oct 2009
- First submitted
- 29 Nov 2007
- Last updated
- 7 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Treatment-Relapsed and Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT00565539
- Acronym / sponsor ID
- 526F06
- Conditions
- Hepatitis C, Chronic
- Keywords
- PEGylated recombinant interleukin 29, interferon lambda, interleukin 29, hepatitis C, virus, infection, liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ZymoGeneticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 30 Nov 2007 (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 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 hepatitis C infection who have received no prior treatment for this disease or who have relapsed following previous treatment with PEGylated interferon alpha (PEG-IFN-α), or other form of IFN-α, and ribavirin.
Detailed description
This is a 3-part study of PEG-rIL-29 in subjects with chronic genotype 1 hepatitis C virus infection who have either received no prior treatment with a PEGylated IFN-α (or other form of IFN-α) or 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 to treatment-relapsed subjects. Part 2 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin administered over a 4-week period to treatment-relapsed subjects. Part 3 of the study will evaluate dose levels and/or schedules of PEG-rIL-29 in combination with daily oral ribavirin administered over a 4-week period to subjects who have received no prior treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Relapsed subjects (Parts 1 and 2) -- Prior treatment for HCV with PEG-IFN-alpha (or other IFN-alpha) and ribavirin for at least 12 weeks. Naive subjects (Part 3) -- No prior treatment with PEG-IFN-alpha (or other IFN-alpha)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| PEGylated recombinant interleukin 29 (PEG-rIL-29)Also: PEGylated interferon lambda (PEG-IFN lambda)subcutaneous administration either weekly or every other week | Drug | – |
Primary outcome
Adverse events and standard clinical laboratory abnormalities
Time frame: Day 59
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2009.
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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.
Diana F Hausman, MD study director
ZymoGenetics
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEGylated recombinant interleukin 29 (PEG-rIL-29) in people with Hepatitis C, Chronic, run by ZymoGenetics at 11 sites in 2 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 7 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: finished, as of the sponsor's last update on 7 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events and standard clinical laboratory abnormalities (time frame: Day 59). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2009.