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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00947349

First received: July 21, 2009

Last updated: April 26, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 21, 2009

Last Updated Date

April 26, 2012

Start Date ^ICMJE

July 2009

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adverse Events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Laboratory test abnormalities [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Laboratory test value changes over time [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

There is no primary endpoint of efficacy in this trial. Instead, safety for the triple combination therapy will be assessed based on: 1. Adverse Events 2. Laboratory test abnormalities 3. Laboratory test value changes over time 4. Tolerability [ Time Frame: 4 weeks ]

Change History

Complete list of historical versions of study NCT00947349 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Trough concentrations [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Safety for the standard therapy [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
Loss of virological response at week 4, 12, 24, 48 and 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Plasma concentration time profile and pharmacokinetic parameters after the first dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Loss of virological response at week 4, 12, 24, 48 and 72 [ Time Frame: 72 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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 Interferona-2a and Ribavirin

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis C
Pharmacokinetics

Intervention ^ICMJE

Drug: BI 201335 llow placebo
Placebo with IFN/RBV
Drug: BI 201335 low
BI 201335 with IFN/RBV
Drug: BI 201335 high
BI 201335 high with IFN/RBV
Drug: BI 201335 high placebo
placebo with IFN/RBV
Drug: BI201335 high
BI 201335 high with IFN/RBV

Study Arm (s)

Experimental: BI 201335 NA low TN
patient to receive a capsule containing low dose of BI 201335 NA/Drug for TN patients
Interventions:
- Drug: BI 201335 llow placebo
- Drug: BI 201335 low
Experimental: BI 201335 NA high TN
patient to receive a capsule containing high dose of BI 201335 NA/Drug for TN patients
Interventions:
- Drug: BI 201335 high
- Drug: BI 201335 high placebo
Experimental: BI 201335 NA high TE
patient to receive a capsule containing high dose of BI 201335 NA/Drug for TE patients

Intervention: Drug: BI201335 high

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

chronic HCV GT1;
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

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00947349

Other Study ID Numbers ^ICMJE

1220.14

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim Pharmaceuticals

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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