Clinical trial NCT00947349: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients
Official title: Safety, Pharmacokinetics and Antiviral Effect of BI 201335 NA in HCV-1 Infected Patients Treated for 28 Days for Treatment naïve and Experienced Patients Treated in Combination With Peg Interferon Alfa-2a and Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Pharmacokinetics
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-07-28
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications.

A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients


Eligibility criteria: Inclusion criteria:

* chronic HCV genotype-1;
* high viral load

Exclusion criteria:

* Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening
* Previous treatment with protease inhibitor

Primary outcomes:
measure: Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy
timeFrame: 4 weeks
measure: Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
timeFrame: 4 weeks
measure: Assessment of Tolerability in Triple Combination Therapy
timeFrame: 4 weeks
Secondary outcomes:
measure: Week 2 Virological Response (W2VR)
timeFrame: 2 weeks
measure: Week 4 Virological Response (W4VR)
timeFrame: 4 weeks
measure: Rapid Virological Response (RVR)
timeFrame: 4 weeks
measure: Change From Baseline in HCV Viral Load
timeFrame: baseline and week 4
measure: Day 28 Virologic Response
timeFrame: 4 weeks
measure: Early Virological Response (EVR)
timeFrame: 12 Weeks
measure: Complete Early Virological Response (cEVR)
timeFrame: 12 weeks
measure: End of Treatment Response (ETR)
timeFrame: 48 weeks
measure: Sustained Virologic Response (SVR)
timeFrame: 72 weeks
measure: Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV
timeFrame: 44 weeks
measure: Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
timeFrame: 44 weeks
measure: Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV
timeFrame: 44 weeks
measure: AUCτ,1 for BI 201335 ZW
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
measure: Cmax of BI 201335 ZW
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
measure: AUCτ,ss of BI 201335 ZW
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
measure: Cmax,ss of BI 201335 ZW
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
measure: AUCτ,1 for Ribavirin (RBV)
timeFrame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose
measure: Cmax of RBV
timeFrame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose
measure: AUCτ,ss of RBV
timeFrame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose
measure: Cmax,ss of RBV
timeFrame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose
measure: Tmax for BI 201335 ZW
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
measure: Tmax for RBV
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
measure: Tmax, ss for BI 201335 ZW
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
measure: Tmax, ss for RBV
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
measure: t1/2,ss for BI 201335 ZW
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
measure: Cmin,ss for BI 201335 ZW
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
measure: Cmin,ss for RBV
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
measure: Cavg for BI 201335 ZW
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
measure: Cavg for RBV
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
measure: CL/F,ss for BI 201335 ZW
timeFrame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Other outcomes:
Locations:
city: Kurashiki, Okayama
country: Japan
facility: 1220.14.003 Boehringer Ingelheim Investigational Site
city: Minato-ku, Tokyo
country: Japan
facility: 1220.14.001 Boehringer Ingelheim Investigational Site
city: Nishinomiya, Hyogo
country: Japan
facility: 1220.14.002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: