Trials / Completed
CompletedNCT00823862
Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study of SD-101 to Assess the Safety, Pharmacodynamics, and Preliminary Evidence of Anti-Viral Effect in Subjects Diagnosed With Chronic Hepatitis C, Genotype 1
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Dynavax Technologies Corporation · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SD-101 | Intramuscular (IM) |
| DRUG | ribavirin | oral, 2 times per day, for 2 months |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2009-12-01
- Completion
- 2010-02-01
- First posted
- 2009-01-16
- Last updated
- 2019-04-16
Locations
5 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT00823862. Inclusion in this directory is not an endorsement.