Trials / Completed
CompletedNCT02176525
Multiple Oral Doses of BI 207127 NA in Treatment naïve and Treatment-experienced Hepatitis C Virus (HCV)-Infected Patients
Safety, Antiviral Activity, and Pharmacokinetics of Multiple Oral Doses of BI 207127 NA Administered q8H for 5 Days as Monotherapy, a Randomised, Double-blind, Placebo Controlled Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both treatment-naïve patients and patients previously treated with peginterferon and ribavirin were included. In addition, the effect of study medication was examined in a group of patients with liver cirrhosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 207127 NA | |
| DRUG | Placebo |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2009-12-01
- First posted
- 2014-06-27
- Last updated
- 2016-06-06
- Results posted
- 2016-06-06
Source: ClinicalTrials.gov record NCT02176525. Inclusion in this directory is not an endorsement.