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A Phase 2 Trial of NOV-205 in Chronic Viral Hepatitis C Patients (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin
The purpose of this research study is to find out the effect of the investigational drug NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated at different doses when taken by subjects with hepatitis C.
Details
| Lead sponsor | Cellectar Biosciences, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 22 |
| Start date | 2010-03 |
| Completion | 2010-12 |
Conditions
- Hepatitis C
Interventions
- NOV-205
Primary outcomes
- To evaluate changes in viral load — 16 months
- To evaluate changes in serum ALT and AST levels — 16 months
- To evaluate the durability of any changes in viral load and serum ALT and AST — 16 months
- To establish the safety profile of NOV-205 — 16 months
Countries
United States