A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients
Public ClinicalTrials.gov record NCT01330316. 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, Open-label Study of Once Daily BI 201335 240 mg for 24 Weeks in Combination With Pegylated interferon-a (PegIFN) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN / RBV Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.
Study identification
- NCT ID
- NCT01330316
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 119 participants
Conditions and interventions
Conditions
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
- Jul 2011 (Type not available)
- Primary completion
- Jun 2014 (Actual)
- Completion
- Jun 2014 (Actual)
- Last update posted
- Jun 30, 2016
2011 – 2014
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1220.48.0004 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1220.48.0091 Boehringer Ingelheim Investigational Site | North Little Rock | Arkansas | — | — |
| 1220.48.0011 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1220.48.0018 Boehringer Ingelheim Investigational Site | Oceanside | California | — | — |
| 1220.48.0078 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | — | — |
| 1220.48.0095 Boehringer Ingelheim Investigational Site | Palm Harbor | Florida | — | — |
| 1220.48.0039 Boehringer Ingelheim Investigational Site | Columbus | Georgia | — | — |
| 1220.48.0013 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1220.48.0087 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | — | — |
| 1220.48.0027 Boehringer Ingelheim Investigational Site | Framingham | Massachusetts | — | — |
| 1220.48.0065 Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | — | — |
| 1220.48.0023 Boehringer Ingelheim Investigational Site | Tupelo | Mississippi | — | — |
| 1220.48.0066 Boehringer Ingelheim Investigational Site | Neptune City | New Jersey | — | — |
| 1220.48.0012 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.48.0058 Boehringer Ingelheim Investigational Site | Portland | Oregon | — | — |
| 1220.48.0063 Boehringer Ingelheim Investigational Site | Arlington | Texas | — | — |
| 1220.48.0029 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
| 1220.48.0017 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1220.48.0071 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1220.48.0081 Boehringer Ingelheim Investigational Site | Forth Worth | 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 67 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01330316, 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 Jun 30, 2016 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01330316 live on ClinicalTrials.gov.