NCT00793793

Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced

Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients. A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	BI201335	patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
DRUG	BI201335	patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
DRUG	BI201335	patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
DRUG	BI201335	patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
DRUG	Placebo

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-25
• First posted: 2008-11-19
• Last updated: 2018-09-05
• Results posted: 2015-09-17

Locations

16 sites across 4 countries: United States, France, Germany, Spain