ClinicalTrials.gov record
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)
ClinicalTrials.gov ID: NCT01297270
Public ClinicalTrials.gov record NCT01297270. 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, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
Study identification
- NCT ID
- NCT01297270
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 658 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
- Apr 2011 (Type not available)
- Primary completion
- Apr 2014 (Actual)
- Completion
- Apr 2014 (Actual)
- Last update posted
- Sep 18, 2015
2011 – 2014
United States locations
- U.S. sites
- 78
- U.S. states
- 26
- U.S. cities
- 61
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1220.47.0004 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1220.47.0045 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1220.47.0050 Boehringer Ingelheim Investigational Site | Dothan | Alabama | — | — |
| 1220.47.0061 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | — | — |
| 1220.47.0091 Boehringer Ingelheim Investigational Site | North Little Rock | Arkansas | — | — |
| 1220.47.0008 Boehringer Ingelheim Investigational Site | Bakersfield | California | — | — |
| 1220.47.0019 Boehringer Ingelheim Investigational Site | Chula Vista | California | — | — |
| 1220.47.0010 Boehringer Ingelheim Investigational Site | Coronado | California | — | — |
| 1220.47.0033 Boehringer Ingelheim Investigational Site | La Jolla | California | — | — |
| 1220.47.0035 Boehringer Ingelheim Investigational Site | La Mesa | California | — | — |
| 1220.47.0011 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1220.47.0014 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1220.47.0100 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1220.47.0018 Boehringer Ingelheim Investigational Site | Oceanside | California | — | — |
| 1220.47.0059 Boehringer Ingelheim Investigational Site | Poway | California | — | — |
| 1220.47.0024 Boehringer Ingelheim Investigational Site | San Diego | California | — | — |
| 1220.47.0037 Boehringer Ingelheim Investigational Site | San Diego | California | — | — |
| 1220.47.0031 Boehringer Ingelheim Investigational Site | San Francisco | California | — | — |
| 1220.47.0082 Boehringer Ingelheim Investigational Site | Englewood | Colorado | — | — |
| 1220.47.0049 Boehringer Ingelheim Investigational Site | New Haven | Connecticut | — | — |
| 1220.47.0057 Boehringer Ingelheim Investigational Site | Bradenton | Florida | — | — |
| 1220.47.0078 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | — | — |
| 1220.47.0086 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | — | — |
| 1220.47.0054 Boehringer Ingelheim Investigational Site | Hialeah | Florida | — | — |
| 1220.47.0088 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1220.47.0044 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 1220.47.0099 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 1220.47.0095 Boehringer Ingelheim Investigational Site | Palm Harbor | Florida | — | — |
| 1220.47.0074 Boehringer Ingelheim Investigational Site | Tampa | Florida | — | — |
| 1220.47.0022 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | — | — |
| 1220.47.0039 Boehringer Ingelheim Investigational Site | Columbus | Georgia | — | — |
| 1220.47.0052 Boehringer Ingelheim Investigational Site | Decatur | Georgia | — | — |
| 1220.47.0013 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1220.47.0055 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1220.47.0062 Boehringer Ingelheim Investigational Site | Vaiparaiso | Indiana | — | — |
| 1220.47.0085 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | — | — |
| 1220.47.0087 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | — | — |
| 1220.47.0101 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | — | — |
| 1220.47.0064 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | — | — |
| 1220.47.0069 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | — | — |
| 1220.47.0067 Boehringer Ingelheim Investigational Site | Chevy Chase | Maryland | — | — |
| 1220.47.0079 Boehringer Ingelheim Investigational Site | Lutherville | Maryland | — | — |
| 1220.47.0027 Boehringer Ingelheim Investigational Site | Framingham | Massachusetts | — | — |
| 1220.47.0065 Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | — | — |
| 1220.47.0023 Boehringer Ingelheim Investigational Site | Tulepo | Mississippi | — | — |
| 1220.47.0046 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | — | — |
| 1220.47.0066 Boehringer Ingelheim Investigational Site | Neptune City | New Jersey | — | — |
| 1220.47.0083 Boehringer Ingelheim Investigational Site | Brooklyn | New York | — | — |
| 1220.47.0003 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.47.0006 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.47.0038 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.47.0090 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1220.47.0097 Boehringer Ingelheim Investigational Site | The Bronx | New York | — | — |
| 1220.47.0053 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | — | — |
| 1220.47.0021 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | — | — |
| 1220.47.0098 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | — | — |
| 1220.47.0028 Boehringer Ingelheim Investigational Site | Portland | Oregon | — | — |
| 1220.47.0058 Boehringer Ingelheim Investigational Site | Portland | Oregon | — | — |
| 1220.47.0030 Boehringer Ingelheim Investigational Site | Germantown | Tennessee | — | — |
| 1220.47.0072 Boehringer Ingelheim Investigational Site | Jackson | Tennessee | — | — |
| 1220.47.0032 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | — | — |
| 1220.47.0041 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | — | — |
| 1220.47.0063 Boehringer Ingelheim Investigational Site | Arlington | Texas | — | — |
| 1220.47.0029 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
| 1220.47.0017 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1220.47.0056 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1220.47.0071 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1220.47.0060 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | — | — |
| 1220.47.0081 Boehringer Ingelheim Investigational Site | Forth Worth | Texas | — | — |
| 1220.47.0009 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1220.47.0068 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1220.47.0016 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1220.47.0015 Boehringer Ingelheim Investigational Site | Burlington | Vermont | — | — |
| 1220.47.0042 Boehringer Ingelheim Investigational Site | Annandale | Virginia | — | — |
| 1220.47.0043 Boehringer Ingelheim Investigational Site | Falls Church | Virginia | — | — |
| 1220.47.0026 Boehringer Ingelheim Investigational Site | Richmond | Virginia | — | — |
| 1220.47.0092 Boehringer Ingelheim Investigational Site | Seattle | Washington | — | — |
| 1220.47.0073 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin | — | — |
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 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01297270, 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 Sep 18, 2015 · Synced Oct 20, 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 NCT01297270 live on ClinicalTrials.gov.