Phase 2
N=140
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
Genotype 1 Chronic Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00606086 ↗Enrolled (actual)
140
Serious AEs
15.4%
Results posted
Jun 2014
Primary outcome: Primary: EVR (Early Virologic Response) — 79.4; 78.5 percentage of participants — p=1.000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GI-5005 (Drug); Pegylated Interferon and Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlobeImmune
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EVR (Early Virologic Response) |
79.4; 78.5 | 1.000 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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;
- 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;
Data sourced from ClinicalTrials.gov (NCT00606086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.