Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
Public ClinicalTrials.gov record NCT01358864. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment
Study identification
- NCT ID
- NCT01358864
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Boehringer Ingelheim
- Industry
- Enrollment
- 678 participants
Conditions and interventions
Conditions
Interventions
- BI 201335 Drug
- Pegylated Interferon-alpha (IFN) Drug
- Ribavirin (RBV) Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2011
- Primary completion
- Jan 31, 2013
- Completion
- Apr 30, 2014
- Last update posted
- Aug 28, 2016
2011 – 2014
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1220.7.0091 Boehringer Ingelheim Investigational Site | North Little Rock | Arkansas | — | — |
| 1220.7.0082 Boehringer Ingelheim Investigational Site | Englewood | Colorado | — | — |
| 1220.7.0095 Boehringer Ingelheim Investigational Site | Palm Harbor | Florida | — | — |
| 1220.7.0039 Boehringer Ingelheim Investigational Site | Columbus | Georgia | — | — |
| 1220.7.0013 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1220.7.0062 Boehringer Ingelheim Investigational Site | Vaiparaiso | Indiana | — | — |
| 1220.7.0085 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | — | — |
| 1220.7.0087 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | — | — |
| 1220.7.0101 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | — | — |
| 1220.7.0027 Boehringer Ingelheim Investigational Site | Framingham | Massachusetts | — | — |
| 1220.7.0012 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.7.0077 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | — | — |
| 1220.7.0058 Boehringer Ingelheim Investigational Site | Portland | Oregon | — | — |
| 1220.7.0063 Boehringer Ingelheim Investigational Site | Arlington | Texas | — | — |
| 1220.7.0029 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
| 1220.7.0071 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1220.7.0009 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1220.7.0016 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 98 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01358864, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 28, 2016 · Synced Jun 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01358864 live on ClinicalTrials.gov.