NCT00774397View on ClinicalTrials.gov

Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

PHASE2CompletedINTERVENTIONAL
Enrollment

719

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

November 30, 2011

Conditions
Hepatitis C, Chronic
Interventions
DRUG

BI 201335 NA 240 mg QD / LI

240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks

DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

DRUG

BI 201335 NA 120mg QD / LI

120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks

DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

DRUG

BI 201335 NA 240 mg QD

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

DRUG

BI 201335 NA 240 mg QD

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

DRUG

BI 201335 NA 240 mg BID

240mg BI 201335 NA (Faldaprevir) twice, 24 weeks

DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

DRUG

BI 201335 NA 240 mg QD

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

DRUG

PegIFN/RBV

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

DRUG

Placebo

Placebo

Trial Locations (100)

Unknown

1220.5.0001 Boehringer Ingelheim Investigational Site, San Francisco

1220.5.0008 Boehringer Ingelheim Investigational Site, San Francisco

1220.5.0005 Boehringer Ingelheim Investigational Site, Chicago

1220.5.0006 Boehringer Ingelheim Investigational Site, Lutherville

1220.5.0002 Boehringer Ingelheim Investigational Site, New York

1220.5.0003 Boehringer Ingelheim Investigational Site, New York

1220.5.0007 Boehringer Ingelheim Investigational Site, Philadelphia

1220.5.0010 Boehringer Ingelheim Investigational Site, Germantown

1220.5.0009 Boehringer Ingelheim Investigational Site, Nashville

1220.5.0004 Boehringer Ingelheim Investigational Site, Austin

1220.5.5401 Boehringer Ingelheim Investigational Site, Capital Federal

1220.5.5403 Boehringer Ingelheim Investigational Site, Capital Federal

1220.5.5405 Boehringer Ingelheim Investigational Site, Derqui, Pilar

1220.5.5402 Boehringer Ingelheim Investigational Site, Rosario

1220.5.5406 Boehringer Ingelheim Investigational Site, Rosario

1220.5.6110 Boehringer Ingelheim Investigational Site, Camperdown

1220.5.6109 Boehringer Ingelheim Investigational Site, Kogarah

1220.5.6105 Boehringer Ingelheim Investigational Site, Randwick

1220.5.6101 Boehringer Ingelheim Investigational Site, Westmead

1220.5.6103 Boehringer Ingelheim Investigational Site, Herston

1220.5.6104 Boehringer Ingelheim Investigational Site, Woolloongabba

1220.5.6102 Boehringer Ingelheim Investigational Site, Clayton

1220.5.6107 Boehringer Ingelheim Investigational Site, Fitzroy

1220.5.6108 Boehringer Ingelheim Investigational Site, Parkville

1220.5.4303 Boehringer Ingelheim Investigational Site, Linz

1220.5.4301 Boehringer Ingelheim Investigational Site, Vienna

1220.5.4302 Boehringer Ingelheim Investigational Site, Vienna

1220.5.1003 Boehringer Ingelheim Investigational Site, Edmonton

1220.5.1007 Boehringer Ingelheim Investigational Site, Vancouver

1220.5.1006 Boehringer Ingelheim Investigational Site, Hamilton

1220.5.1001 Boehringer Ingelheim Investigational Site, Ottawa

1220.5.1002 Boehringer Ingelheim Investigational Site, Toronto

1220.5.1004 Boehringer Ingelheim Investigational Site, Montreal

1220.5.4202 Boehringer Ingelheim Investigational Site, Mělník

1220.5.4203 Boehringer Ingelheim Investigational Site, Opava

1220.5.3301A Boehringer Ingelheim Investigational Site, Clichy

1220.5.3307A Boehringer Ingelheim Investigational Site, Créteil

1220.5.3309A Boehringer Ingelheim Investigational Site, Lyon

1220.5.3304A Boehringer Ingelheim Investigational Site, Marseille

1220.5.3306A Boehringer Ingelheim Investigational Site, Montpellier

1220.5.3302A Boehringer Ingelheim Investigational Site, Paris

1220.5.3303A Boehringer Ingelheim Investigational Site, Paris

1220.5.3308A Boehringer Ingelheim Investigational Site, Paris

1220.5.3305A Boehringer Ingelheim Investigational Site, Vandœuvre-lès-Nancy

1220.5.4902 Boehringer Ingelheim Investigational Site, Berlin

1220.5.4903 Boehringer Ingelheim Investigational Site, Berlin

1220.5.4917 Boehringer Ingelheim Investigational Site, Berlin

1220.5.4914 Boehringer Ingelheim Investigational Site, Bochum

1220.5.4913 Boehringer Ingelheim Investigational Site, Bonn

1220.5.4915 Boehringer Ingelheim Investigational Site, Dortmund

1220.5.4905 Boehringer Ingelheim Investigational Site, Düsseldorf

1220.5.4912 Boehringer Ingelheim Investigational Site, Düsseldorf

1220.5.4906 Boehringer Ingelheim Investigational Site, Frankfurt am Main

1220.5.4908 Boehringer Ingelheim Investigational Site, Hamburg

1220.5.4904 Boehringer Ingelheim Investigational Site, Hanover

1220.5.4910 Boehringer Ingelheim Investigational Site, Leipzig

1220.5.4909 Boehringer Ingelheim Investigational Site, Mainz

1220.5.4907 Boehringer Ingelheim Investigational Site, Tübingen

1220.5.3101 Boehringer Ingelheim Investigational Site, Amsterdam

1220.5.3102 Boehringer Ingelheim Investigational Site, Leiden

1220.5.3501 Boehringer Ingelheim Investigational Site, Coimbra

1220.5.3504 Boehringer Ingelheim Investigational Site, Coimbra

1220.5.3502 Boehringer Ingelheim Investigational Site, Lisbon

1220.5.3503 Boehringer Ingelheim Investigational Site, Lisbon

1220.5.3506 Boehringer Ingelheim Investigational Site, Porto

1220.5.3507 Boehringer Ingelheim Investigational Site, Porto

1220.5.4001 Boehringer Ingelheim Investigational Site, Bucharest

1220.5.4002 Boehringer Ingelheim Investigational Site, Bucharest

1220.5.4003 Boehringer Ingelheim Investigational Site, Bucharest

1220.5.4004 Boehringer Ingelheim Investigational Site, Bucharest

1220.5.8210 Boehringer Ingelheim Investigational Site, Busan

1220.5.8205 Boehringer Ingelheim Investigational Site, Daegu

1220.5.8201 Boehringer Ingelheim Investigational Site, Pusan

1220.5.8202 Boehringer Ingelheim Investigational Site, Seoul

1220.5.8206 Boehringer Ingelheim Investigational Site, Seoul

1220.5.8207 Boehringer Ingelheim Investigational Site, Seoul

1220.5.8208 Boehringer Ingelheim Investigational Site, Seoul

1220.5.8204 Boehringer Ingelheim Investigational Site, Seoungnam

1220.5.8203 Boehringer Ingelheim Investigational Site, Sungnam

1220.5.8209 Boehringer Ingelheim Investigational Site, Suwon

1220.5.8211 Boehringer Ingelheim Investigational Site, Yangsan

1220.5.3402 Boehringer Ingelheim Investigational Site, Barcelona

1220.5.3405 Boehringer Ingelheim Investigational Site, Barcelona

1220.5.3401 Boehringer Ingelheim Investigational Site, Madrid

1220.5.3403 Boehringer Ingelheim Investigational Site, Madrid

1220.5.3404 Boehringer Ingelheim Investigational Site, Madrid

1220.5.3406 Boehringer Ingelheim Investigational Site, Madrid

1220.5.4104 Boehringer Ingelheim Investigational Site, Bern

1220.5.4102 Boehringer Ingelheim Investigational Site, La Chaux-de-Fonds

1220.5.4103 Boehringer Ingelheim Investigational Site, Lugano

1220.5.4101 Boehringer Ingelheim Investigational Site, Zurich

1220.5.4106 Boehringer Ingelheim Investigational Site, Zurich

1220.5.4405 Boehringer Ingelheim Investigational Site, Bristol

1220.5.4401 Boehringer Ingelheim Investigational Site, London

1220.5.4402 Boehringer Ingelheim Investigational Site, London

1220.5.4406 Boehringer Ingelheim Investigational Site, London

1220.5.4409 Boehringer Ingelheim Investigational Site, London

1220.5.4410 Boehringer Ingelheim Investigational Site, London

1220.5.4408 Boehringer Ingelheim Investigational Site, Nottingham

1220.5.4403 Boehringer Ingelheim Investigational Site, Southampton

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT00774397 - Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2) | Biotech Hunter | Biotech Hunter