Trials / Completed
CompletedNCT01200420
Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (Miravirsen) Administered to Treatment-Naïve Subjects With Chronic Hepatitis C (CHC) Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Santaris Pharma A/S · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C. Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | miravirsen | SC injection |
| DRUG | saline | SC injection |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2010-09-13
- Last updated
- 2012-01-31
Locations
7 sites across 6 countries: United States, Germany, Netherlands, Poland, Puerto Rico, Slovakia
Source: ClinicalTrials.gov record NCT01200420. Inclusion in this directory is not an endorsement.