Study of AVI-4065 in Healthy Volunteers and Chronic Active HCV Patients
Summary
Chronic active hepatitis C viral infections are difficult to treat: current drug therapies can result in severe side effects that some patients will not tolerate. AVI-4065 Injection is a new drug designed to prevent the virus from reproducing in the body. We tested this drug in healthy adult volunteers to optimize the dosing regimen, and are now proceeding in adult patients with chronic active hepatitis C infections. Patients who have the disease and who have had treatment but without success, will be recruited for the study. The treatment of HCV patients initially consisted of subcutaneous injections given twice a day for 14-days. Treatment arms of 28 days, twice or three-times per day have been added.
Timeline
- Start
- 2005-09
- Primary completion
- 2006-10
- Completion
- 2007-01
Outcome
Missed primary endpoint
Stopped: “Limited viral load reduction in HCV subjects”
release “AVI-4065. Following disappointing results from two small Phase 1 studies in HCV patients in which less-than-expected reductions in viral titer were observed” sarepta.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AVI-4065 | Oligonucleotide (other) | — | Subcutaneous |