Genotype 1 Chronic Hepatitis CPhase 2NCT00606086
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection
A Phase 2 study testing GI-5005 and Pegylated Interferon and Ribavirin in people with Genotype 1 Chronic Hepatitis C, run by GlobeImmune at 25 sites in United States.
Trial summary
The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genotype 1 Chronic Hepatitis C
- What is being tested?
- GI-5005 and Pegylated Interferon 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
- 140 participants
- Where
- 25 sitesUnited States
- Study dates
- Dec 2007to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis C infection with genotype 1 based on serum positivity for HCV RNA or a positive test for serum anti-HCV antibody for at least 6 months;
- One of the following response criteria based on response to prior combination therapy with pegylated or non-pegylated interferon plus ribavirin:
- Non-Responders
- Poor responders - a subset of non-responders who achieved > 1 log10 but < 2 log10 reduction in HCV RNA after a minimum of 12 weeks of prior interferon based therapy.
- Partial responders - a subset of non-responders who achieve at least a 2 log10 reduction in HCV RNA by 12 weeks, but do not achieve an end of treatment response (ETR defined as HCV RNA negativity by PCR assay at the end of a minimum of 6 months of therapy).
- Naive
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- Patients who are treatment naïve and have refused IFN therapy for reasons other than contraindication.
- Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed;
- Liver biopsy within 3 years of the screening visit, documenting extent of liver disease consistent with chronic hepatitis C with evidence of inflammation and/or fibrosis. Liver biopsy within 1 year for subjects consenting to paired biopsy testing. Eight unstained liver biopsy slides are required for the baseline sample and post-treatment sample for use in central blinded evaluation for paired biopsy testing;
- Age ≥ 18 years;
- Negative scratch test (immediate hypersensitivity, IgE mediated) to S. cerevisiae.
Who cannot join
- History of decompensated liver disease, including but not restricted to, portal hypertension as manifested by a known history of gastroesophageal varices, variceal bleeding, ascites or encephalopathy, histopathologic or clinical evidence of cirrhosis, hepatocellular carcinoma, or renal impairment consistent with hepatorenal syndrome;
- History of significant non-HCV chronic liver disease, i.e. alcoholic hepatitis, autoimmune hepatitis;
- Null response to prior IFN plus ribavirin therapy, defined as patients that have received at least 12 weeks of interferon-based treatment with < 1 log10 reduction in viral load;
- Subjects treated with more than 1 complete hepatitis C regimen (subjects with a history of 1 complete prior regimen and a second incomplete prior regimen may be eligible upon discussion with and approval of the medical monitor);
- Subjects that required a dose reduction of >25% of the planned exposure of IFN or >50% of their planned ribavirin exposure during their previous interferon/ribavirin treatment;
- Subjects that required growth factors during their previous interferon/ribavirin treatment;
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- Subjects that received small molecule inhibitor therapy combined with an interferon based regimen. (subjects that received small molecule inhibitor monotherapy can be included);
- Treatment for HCV infection within 28 days before screening;
- Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at screening;
- Body weight >275 pounds;
- Known history of HIV infection or positive HIV antibody test at screening;
- History of Crohn's disease or ulcerative colitis;
- Concurrent therapy with herbal supplements taken specifically for the treatment of HCV (i.e. milk thistle). Wash-out of HCV related herbals for 28 days prior to Day 1. Consult sponsor before excluding potential subjects;
- Alcohol and/or IV drug abuse within the past year;
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University of Colorado
Aurora, Colorado, 80045
University of Alabama Birmingham
Birmingham, Alabama, 35294
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
South Denver Gastroenterology
Englewood, Colorado, 80113
University of Connecticut Health Center
Farmingtom, Connecticut, 06030
Hawaii Medical Center
Honolulu, Hawaii, 96817
Baylor College of Medicine
Houston, Texas, 77030
Gastroenterology Associates, PA
Jackson, Mississippi, 39202
Scripps Clinic Torrey Pines
La Jolla, California, 92037
Maryland Digestive Disease Research
Laurel, Maryland, 20707
NW Georgia Research Institute
Marietta, Georgia, 30060
Yale University School of Medicine
New Haven, Connecticut, 06520
Tulane University Hospital
New Orleans, Louisiana
Weill Medical College of Cornell University
New York, New York, 10021
Columbia University
New York, New York, 10032
Liver Institute of Virginia Bon Secours Health System
Newport News, Virginia, 23602
McGuire VA Medical Center
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
Alamo Medical Research
San Antonio, Texas, 78215
Research and Education inc.
San Diego, California, 92105
St. Louis University
St Louis, Missouri, 63104
University of Arizona
Tucson, Arizona, 85724
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383
About this study
Official title: A Phase 2 Randomized, Open Label, Multi-center, Therapeutic Trial of the Efficacy, Immunogenicity, and Safety of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone, and GI-5005 Salvage of Standard of Care Failures, in Patients With Genotype 1 Chronic Hepatitis C Infection
The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR.
- Conditions
- Genotype 1 Chronic Hepatitis C
- Being tested
- GI-5005, Pegylated Interferon and Ribavirin
- Keywords
- Hepatitis, HCV, Liver disease, HepC
- Medical subject headings
- Hepatitis, Hepatitis C, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI-5005Drug
Also called Pegasys and Ribavirin
40YU, subcutaneous
Pegylated Interferon and RibavirinDrug
Also called Pegasys and Ribavirin
Pegylated interefron is an injection and ribavirin is an oral tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GI-5005 monotherapy continuing on to triple therapy Receives: Drug: GI-5005 |
| 2 | Active comparator | Standard of care alone Receives: Drug: GI-5005; Drug: Pegylated Interferon and Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVR (Early Virologic Response)
Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.
Measured: At 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Genotype 1 Chronic Hepatitis CStudies 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
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlobeImmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606086
- Sponsor's protocol ID
- GI-5005-02
- Status last verified
- May 2014
- First submitted
- 18 Jan 2008
- Last updated
- 27 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Open Label, Multi-center, Therapeutic Trial of the Efficacy, Immunogenicity, and Safety of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone, and GI-5005 Salvage of Standard of Care Failures, in Patients With Genotype 1 Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT00606086
- Acronym / sponsor ID
- GI-5005-02
- Conditions
- Genotype 1 Chronic Hepatitis C
- Keywords
- Hepatitis, HCV, Liver disease, HepC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- GlobeImmuneIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Feb 2008 (estimated)
- Results
- Posted 3 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GI-5005GI-5005 monotherapy continuing on to triple therapy |
| 2 | Active comparator | Drug: GI-5005, Drug: Pegylated Interferon and RibavirinStandard of care alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Chronic hepatitis C infection with genotype 1 based on serum positivity for HCV RNA or a positive test for serum anti-HCV antibody for at least 6 months;
- One of the following response criteria based on response to prior combination therapy with pegylated or non-pegylated interferon plus ribavirin:
- Non-Responders
- Poor responders - a subset of non-responders who achieved > 1 log10 but < 2 log10 reduction in HCV RNA after a minimum of 12 weeks of prior interferon based therapy.
- Partial responders - a subset of non-responders who achieve at least a 2 log10 reduction in HCV RNA by 12 weeks, but do not achieve an end of treatment response (ETR defined as HCV RNA negativity by PCR assay at the end of a minimum of 6 months of therapy).
Key exclusion criteria (14 listed)
- History of decompensated liver disease, including but not restricted to, portal hypertension as manifested by a known history of gastroesophageal varices, variceal bleeding, ascites or encephalopathy, histopathologic or clinical evidence of cirrhosis, hepatocellular carcinoma, or renal impairment consistent with hepatorenal syndrome;
- History of significant non-HCV chronic liver disease, i.e. alcoholic hepatitis, autoimmune hepatitis;
- Null response to prior IFN plus ribavirin therapy, defined as patients that have received at least 12 weeks of interferon-based treatment with < 1 log10 reduction in viral load;
- Subjects treated with more than 1 complete hepatitis C regimen (subjects with a history of 1 complete prior regimen and a second incomplete prior regimen may be eligible upon discussion with and approval of the medical monitor);
- Subjects that required a dose reduction of >25% of the planned exposure of IFN or >50% of their planned ribavirin exposure during their previous interferon/ribavirin treatment;
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 |
|---|---|---|
| GI-5005Also: Pegasys and Ribavirin40YU, subcutaneous | Drug | 1, 2 |
| Pegylated Interferon and RibavirinAlso: Pegasys and RibavirinPegylated interefron is an injection and ribavirin is an oral tablet | Drug | 2 |
Primary outcome
EVR (Early Virologic Response)
Time frame: At 12 weeks of treatment
Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor WebsiteLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GI-5005 and Pegylated Interferon and Ribavirin in people with Genotype 1 Chronic Hepatitis C, run by GlobeImmune at 25 sites in United States.
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 11 inclusion and 14 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
EVR (Early Virologic Response) (time frame: At 12 weeks of treatment). 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 27 Jun 2014.