NCT01132313View on ClinicalTrials.gov

Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

488

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Hepatitis C, Chronic
Interventions
DRUG

BI 207127

28 weeks, high dose, TID

DRUG

BI 201335

40 weeks, QD

DRUG

BI 207127

4 weeks, low dose TID

DRUG

BI 201335

24 weeks, QD

DRUG

Ribavirin

16 weeks, according to label

DRUG

Ribavirin

28 weeks, according to label

DRUG

Ribavirin

28 weeks, according to label

DRUG

BI 207127

40 weeks, high dose, TID

DRUG

BI 207127

24 weeks, very high dose, BID

DRUG

BI 207127

16 weeks, standard dose, BID

DRUG

BI 201335

24 weeks, QD

DRUG

Ribavirin

48 weeks, according to label

DRUG

Ribavirin

40 weeks, according to label

DRUG

BI 207127

16 weeks, high dose, TID

DRUG

BI 207127

28 weeks, high dose, TID

DRUG

BI 201335

28 weeks, QD

DRUG

BI 201335

16 weeks, QD

DRUG

Ribavirin

24 weeks, according to label

DRUG

BI 201335

24 weeks, QD

DRUG

BI 201335

28 weeks, QD

DRUG

BI 207127

24 weeks, standard dose, BID

DRUG

BI 201335

24 weeks, QD

DRUG

BI 201335

16 weeks, QD

DRUG

BI 207127

16 weeks, high dose, BID

DRUG

BI 201335

24 weeks, QD

DRUG

Ribavirin

16 weeks, according to label

DRUG

Ribavirin

16 weeks, according to label

DRUG

BI 207217

28 weeks, high dose BID

DRUG

BI 201335

16 weeks, QD

DRUG

BI 207127

24 weeks, high dose, TID

DRUG

Ribavirin

48 weeks, according to label

DRUG

BI 207127

4 weeks, high dose, TID

DRUG

BI 201335

28 weeks, QD

DRUG

Ribavirin

24 weeks, according to label

DRUG

Ribavirin

24 weeks, according to label

Trial Locations (53)

Unknown

1241.21.0003 Boehringer Ingelheim Investigational Site, La Jolla

1241.21.0006 Boehringer Ingelheim Investigational Site, San Diego

1241.21.0004 Boehringer Ingelheim Investigational Site, San Francisco

1241.21.0011 Boehringer Ingelheim Investigational Site, Palm Harbor

1241.21.0013 Boehringer Ingelheim Investigational Site, Valparaiso

1241.21.0008 Boehringer Ingelheim Investigational Site, Springfield

1241.21.0019 Boehringer Ingelheim Investigational Site, Fayetteville

1241.21.0012 Boehringer Ingelheim Investigational Site, Arlington

1241.21.0005 Boehringer Ingelheim Investigational Site, Austin

1241.21.0007 Boehringer Ingelheim Investigational Site, Dallas

1241.21.0010 Boehringer Ingelheim Investigational Site, Houston

1241.21.0017 Boehringer Ingelheim Investigational Site, Seattle

1241.21.61002 Boehringer Ingelheim Investigational Site, Heidelberg

1241.21.61001 Boehringer Ingelheim Investigational Site, Melbourne

1241.21.43003 Boehringer Ingelheim Investigational Site, Linz

1241.21.43001 Boehringer Ingelheim Investigational Site, Vienna

1241.21.43002 Boehringer Ingelheim Investigational Site, Vienna

1241.21.33005 Boehringer Ingelheim Investigational Site, Clichy

1241.21.33007 Boehringer Ingelheim Investigational Site, Grenoble Cédex 9

1241.21.33003 Boehringer Ingelheim Investigational Site, Lyon

1241.21.33001 Boehringer Ingelheim Investigational Site, Marseille

1241.21.33002 Boehringer Ingelheim Investigational Site, Montpellier

1241.21.33004 Boehringer Ingelheim Investigational Site, Paris

1241.21.33008 Boehringer Ingelheim Investigational Site, Paris

1241.21.33006 Boehringer Ingelheim Investigational Site, Vandœuvre-lès-Nancy

1241.21.49002 Boehringer Ingelheim Investigational Site, Berlin

1241.21.49003 Boehringer Ingelheim Investigational Site, Berlin

1241.21.49007 Boehringer Ingelheim Investigational Site, Düsseldorf

1241.21.49005 Boehringer Ingelheim Investigational Site, Esslingen am Neckar

1241.21.49001 Boehringer Ingelheim Investigational Site, Frankfurt am Main

1241.21.49006 Boehringer Ingelheim Investigational Site, Hamburg

1241.21.49009 Boehringer Ingelheim Investigational Site, Hanover

1241.21.49004 Boehringer Ingelheim Investigational Site, Leipzig

1241.21.49008 Boehringer Ingelheim Investigational Site, Mainz

1241.21.64001 Boehringer Ingelheim Investigational Site, Auckland NZ

1241.21.35103 Boehringer Ingelheim Investigational Site, Aveiro

1241.21.35104 Boehringer Ingelheim Investigational Site, Coimbra

1241.21.35101 Boehringer Ingelheim Investigational Site, Lisbon

1241.21.35105 Boehringer Ingelheim Investigational Site, Lisbon

1241.21.35102 Boehringer Ingelheim Investigational Site, Porto

1241.21.40001 Boehringer Ingelheim Investigational Site, Bucharest

1241.21.40002 Boehringer Ingelheim Investigational Site, Bucharest

1241.21.40003 Boehringer Ingelheim Investigational Site, Bucharest

1241.21.34002 Boehringer Ingelheim Investigational Site, Barcelona

1241.21.34005 Boehringer Ingelheim Investigational Site, Barcelona

1241.21.34003 Boehringer Ingelheim Investigational Site, Madrid

1241.21.34004 Boehringer Ingelheim Investigational Site, Madrid

1241.21.34001 Boehringer Ingelheim Investigational Site, Majadahonda-Madrid

1241.21.34006 Boehringer Ingelheim Investigational Site, Valencia

1241.21.41003 Boehringer Ingelheim Investigational Site, Basel

1241.21.41006 Boehringer Ingelheim Investigational Site, Bern

1241.21.41001 Boehringer Ingelheim Investigational Site, Sankt Gallen

1241.21.41002 Boehringer Ingelheim Investigational Site, Zurich

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY