NCT00947349View on ClinicalTrials.gov

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2011

Conditions
Hepatitis CPharmacokinetics
Interventions
DRUG

ribavirin (RBV)

ribavirin (RBV)

DRUG

pegylated interferon (PegIFN) alfa-2a

pegylated interferon (PegIFN) alfa-2a

DRUG

pegylated interferon (PegIFN) alfa-2a

pegylated interferon (PegIFN) alfa-2a

DRUG

ribavirin (RBV)

ribavirin (RBV)

DRUG

BI 201335 NA low placebo

Placebo

DRUG

pegylated interferon (PegIFN) alfa-2a

pegylated interferon (PegIFN) alfa-2a

DRUG

ribavirin (RBV)

ribavirin (RBV)

DRUG

BI 201335 NA high

BI 201335 NA high

DRUG

BI 201335 NA low

BI 201335 NA

DRUG

BI 201335 NA high placebo

placebo

DRUG

BI 201335 NA high

BI 201335 NA high

DRUG

Placebo

Trial Locations (3)

Unknown

1220.14.003 Boehringer Ingelheim Investigational Site, Kurashiki, Okayama

1220.14.001 Boehringer Ingelheim Investigational Site, Minato-ku, Tokyo

1220.14.002 Boehringer Ingelheim Investigational Site, Nishinomiya, Hyogo

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT00947349 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients | Biotech Hunter | Biotech Hunter