Trials / Completed
CompletedNCT01732796
IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1
A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 470 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ribavirin (RBV) | 24 weeks of active RBV |
| DRUG | BI 201335 (Faldaprevir) | 16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335 |
| DRUG | Ribavirin (RBV) | 24 weeks of active RBV |
| DRUG | BI 207127 | 24 weeks of BI 207127 |
| DRUG | BI 201335 (Faldaprevir) | 24 weeks of BI 201335 |
| DRUG | Ribavirin (RBV) | 16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin |
| DRUG | BI 207127 | 16 weeks BI 207127 followed by 8 weeks placebo to BI 207127 |
| DRUG | Faldaprevir (BI 201335) | 24 weeks of 201335 |
| DRUG | BI 207127 | 24 weeks of BI 207127 |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2012-11-26
- Last updated
- 2016-04-18
- Results posted
- 2016-04-18
Locations
101 sites across 14 countries: United States, Austria, Canada, France, Germany, Hungary, Ireland, Italy, Netherlands, Portugal, Romania, Russia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01732796. Inclusion in this directory is not an endorsement.