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
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.
Timeline
- Start
- 2007-12
- Primary completion
- 2012-11
- Completion
- 2012-11
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Arm 1: Peg-IFN/Ribavirin Plus GI-5005 vs Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005; p = 1.000; Cochran-Mantel-Haenszel test NCT00606086 ↗
registry NUMBER Arm 1: Peg-IFN/Ribavirin Plus GI-5005: 79.4 percentage of participants NCT00606086 ↗
registry NUMBER Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005: 78.5 percentage of participants NCT00606086 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GI-5005 | Vaccine | 40 unknown | Subcutaneous |
| Comparator | Pegylated Interferon | Unknown | — | Other |
| Comparator | Ribavirin | Small molecule | — | Oral |