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Completed Phase 3 Interventional Results available

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.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 11:18 AM EDT

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.

Study identification

NCT ID
NCT01297270
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
658 participants

Conditions and interventions

Conditions

Interventions

  • BI201335 Drug
  • PegIFN/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
Mar 31, 2011
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014
Last update posted
Sep 17, 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 17, 2015 · Synced Jul 21, 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 protocol, eligibility criteria, and contact information for NCT01297270 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →