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)

PHASE3CompletedINTERVENTIONAL
Enrollment

678

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

February 28, 2013

Study Completion Date

May 31, 2014

Conditions
Hepatitis C, Chronic
Interventions
DRUG

BI 201335

BI 201335 once a day (QD) for 24 weeks

DRUG

Pegylated Interferon-alpha (IFN)

Pegylated Interferon-alpha for 48 weeks

DRUG

Ribavirin (RBV)

Ribavirin (RBV) for 24 or 48 weeks

DRUG

Placebo

Placebo to BI201335 for 24 weeks

Trial Locations (116)

Unknown

1220.7.0091 Boehringer Ingelheim Investigational Site, North Little Rock

1220.7.0082 Boehringer Ingelheim Investigational Site, Englewood

1220.7.0095 Boehringer Ingelheim Investigational Site, Palm Harbor

1220.7.0039 Boehringer Ingelheim Investigational Site, Columbus

1220.7.0013 Boehringer Ingelheim Investigational Site, Chicago

1220.7.0062 Boehringer Ingelheim Investigational Site, Vaiparaiso

1220.7.0085 Boehringer Ingelheim Investigational Site, Baton Rouge

1220.7.0087 Boehringer Ingelheim Investigational Site, Baton Rouge

1220.7.0101 Boehringer Ingelheim Investigational Site, New Orleans

1220.7.0027 Boehringer Ingelheim Investigational Site, Framingham

1220.7.0012 Boehringer Ingelheim Investigational Site, New York

1220.7.0077 Boehringer Ingelheim Investigational Site, Winston-Salem

1220.7.0058 Boehringer Ingelheim Investigational Site, Portland

1220.7.0063 Boehringer Ingelheim Investigational Site, Arlington

1220.7.0029 Boehringer Ingelheim Investigational Site, Austin

1220.7.0071 Boehringer Ingelheim Investigational Site, Dallas

1220.7.0009 Boehringer Ingelheim Investigational Site, Houston

1220.7.0016 Boehringer Ingelheim Investigational Site, San Antonio

1220.7.4303 Boehringer Ingelheim Investigational Site, Linz

1220.7.4301 Boehringer Ingelheim Investigational Site, Vienna

1220.7.4302 Boehringer Ingelheim Investigational Site, Vienna

1220.7.3201 Boehringer Ingelheim Investigational Site, Brussels

1220.7.3207 Boehringer Ingelheim Investigational Site, Brussels

1220.7.3204 Boehringer Ingelheim Investigational Site, Edegem

1220.7.3205 Boehringer Ingelheim Investigational Site, Ghent

1220.7.3206 Boehringer Ingelheim Investigational Site, Jette

1220.7.3202 Boehringer Ingelheim Investigational Site, Leuven

1220.7.3203 Boehringer Ingelheim Investigational Site, Liège

1220.7.1011 Boehringer Ingelheim Investigational Site, Calgary

1220.7.1012 Boehringer Ingelheim Investigational Site, Edmonton

1220.7.1003 Boehringer Ingelheim Investigational Site, Vancouver

1220.7.1016 Boehringer Ingelheim Investigational Site, Vancouver

1220.7.1007 Boehringer Ingelheim Investigational Site, Victoria

1220.7.1004 Boehringer Ingelheim Investigational Site, Ottawa

1220.7.1006 Boehringer Ingelheim Investigational Site, Toronto

1220.7.1010 Boehringer Ingelheim Investigational Site, Montreal

1220.7.1014 Boehringer Ingelheim Investigational Site, Montreal

1220.7.3301 Boehringer Ingelheim Investigational Site, Clichy

1220.7.3311 Boehringer Ingelheim Investigational Site, Lille

1220.7.3303 Boehringer Ingelheim Investigational Site, Marseille

1220.7.3304 Boehringer Ingelheim Investigational Site, Montpellier

1220.7.3305 Boehringer Ingelheim Investigational Site, Nice

1220.7.3302 Boehringer Ingelheim Investigational Site, Paris

1220.7.3310 Boehringer Ingelheim Investigational Site, Paris

1220.7.3316 Boehringer Ingelheim Investigational Site, Pessac

1220.7.3317 Boehringer Ingelheim Investigational Site, Reims

1220.7.3315 Boehringer Ingelheim Investigational Site, Rennes

1220.7.3318 Boehringer Ingelheim Investigational Site, Strasbourg

1220.7.3308 Boehringer Ingelheim Investigational Site, Vandœuvre-lès-Nancy

1220.7.4902 Boehringer Ingelheim Investigational Site, Berlin

1220.7.4904 Boehringer Ingelheim Investigational Site, Berlin

1220.7.4913 Boehringer Ingelheim Investigational Site, Dortmund

1220.7.4906 Boehringer Ingelheim Investigational Site, Düsseldorf

1220.7.4901 Boehringer Ingelheim Investigational Site, Frankfurt am Main

1220.7.4908 Boehringer Ingelheim Investigational Site, Hamburg

1220.7.4918 Boehringer Ingelheim Investigational Site, Hanover

1220.7.4907 Boehringer Ingelheim Investigational Site, Herne

1220.7.4903 Boehringer Ingelheim Investigational Site, Leipzig

1220.7.4911 Boehringer Ingelheim Investigational Site, Mainz

1220.7.4905 Boehringer Ingelheim Investigational Site, München

1220.7.8106 Boehringer Ingelheim Investigational Site, Chiba, Chiba

1220.7.8111 Boehringer Ingelheim Investigational Site, Gifu, Gifu

1220.7.8107 Boehringer Ingelheim Investigational Site, Itabashi-ku, Tokyo

1220.7.8112 Boehringer Ingelheim Investigational Site, Izunokuni, Shizuoka

1220.7.8108 Boehringer Ingelheim Investigational Site, Kamakura, Kanagawa

1220.7.8117 Boehringer Ingelheim Investigational Site, Kita-gun, Kagawa

1220.7.8109 Boehringer Ingelheim Investigational Site, Kofu, Yamanashi

1220.7.8116 Boehringer Ingelheim Investigational Site, Kurashiki, Okayama

1220.7.8118 Boehringer Ingelheim Investigational Site, Kurume, Fukuoka

1220.7.8110 Boehringer Ingelheim Investigational Site, Matsumoto, Nagano

1220.7.8124 Boehringer Ingelheim Investigational Site, Matsuyama, Ehime

1220.7.8113 Boehringer Ingelheim Investigational Site, Nagoya, Aichi

1220.7.8105 Boehringer Ingelheim Investigational Site, Namegata, Ibaraki

1220.7.8114 Boehringer Ingelheim Investigational Site, Nishinomiya, Hyogo

1220.7.8125 Boehringer Ingelheim Investigational Site, Ogaki, Gifu

1220.7.8119 Boehringer Ingelheim Investigational Site, Omura, Nagasaki

1220.7.8122 Boehringer Ingelheim Investigational Site, Omuta, Fukuoka

1220.7.8121 Boehringer Ingelheim Investigational Site, Osaka, Osaka

1220.7.8101 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido

1220.7.8102 Boehringer Ingelheim Investigational Site, Sendai, Miyagi

1220.7.8115 Boehringer Ingelheim Investigational Site, Tanabe, Wakayama

1220.7.8123 Boehringer Ingelheim Investigational Site, Toyama,Toyama

1220.7.8126 Boehringer Ingelheim Investigational Site, Tsu, Mie

1220.7.8104 Boehringer Ingelheim Investigational Site, Tsuchiura, Ibaraki

1220.7.3503 Boehringer Ingelheim Investigational Site, Aveiro

1220.7.3509 Boehringer Ingelheim Investigational Site, Barreiro

1220.7.3506 Boehringer Ingelheim Investigational Site, Coimbra

1220.7.3501 Boehringer Ingelheim Investigational Site, Lisbon

1220.7.3505 Boehringer Ingelheim Investigational Site, Lisbon

1220.7.3502 Boehringer Ingelheim Investigational Site, Porto

1220.7.0034 Boehringer Ingelheim Investigational Site, San Juan

1220.7.3406 Boehringer Ingelheim Investigational Site, A Coruña

1220.7.3402 Boehringer Ingelheim Investigational Site, Barcelona

1220.7.3404 Boehringer Ingelheim Investigational Site, Barcelona

1220.7.3411 Boehringer Ingelheim Investigational Site, Barcelona

1220.7.3412 Boehringer Ingelheim Investigational Site, Barcelona

1220.7.3405 Boehringer Ingelheim Investigational Site, Madrid

1220.7.3409 Boehringer Ingelheim Investigational Site, Madrid

1220.7.3410 Boehringer Ingelheim Investigational Site, Majadahonda-Madrid

1220.7.3408 Boehringer Ingelheim Investigational Site, Santander

1220.7.3403 Boehringer Ingelheim Investigational Site, Seville

1220.7.3401 Boehringer Ingelheim Investigational Site, Valencia

1220.7.3407 Boehringer Ingelheim Investigational Site, Vigo (Pontevedra)

1220.7.4106 Boehringer Ingelheim Investigational Site, Bern

1220.7.4103 Boehringer Ingelheim Investigational Site, La Chaux-de-Fonds

1220.7.4107 Boehringer Ingelheim Investigational Site, Lugano

1220.7.4108 Boehringer Ingelheim Investigational Site, Sankt Gallen

1220.7.4101 Boehringer Ingelheim Investigational Site, Zurich

1220.7.4405 Boehringer Ingelheim Investigational Site, Bristol

1220.7.4404 Boehringer Ingelheim Investigational Site, London

1220.7.4409 Boehringer Ingelheim Investigational Site, London

1220.7.4410 Boehringer Ingelheim Investigational Site, London

1220.7.4401 Boehringer Ingelheim Investigational Site, Manchester

1220.7.4408 Boehringer Ingelheim Investigational Site, Nottingham

1220.7.4407 Boehringer Ingelheim Investigational Site, Oxford

1220.7.4403 Boehringer Ingelheim Investigational Site, Southampton

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY