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

NCT ID: NCT00947349

Last Updated: 2015-07-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Hepatitis C Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 201335 NA low TN

patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients

Group Type EXPERIMENTAL

pegylated interferon (PegIFN) alfa-2a

Intervention Type DRUG

pegylated interferon (PegIFN) alfa-2a

BI 201335 NA low placebo

Intervention Type DRUG

Placebo

ribavirin (RBV)

Intervention Type DRUG

ribavirin (RBV)

BI 201335 NA low

Intervention Type DRUG

BI 201335 NA

BI 201335 NA high TN

patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients

Group Type EXPERIMENTAL

ribavirin (RBV)

Intervention Type DRUG

ribavirin (RBV)

pegylated interferon (PegIFN) alfa-2a

Intervention Type DRUG

pegylated interferon (PegIFN) alfa-2a

BI 201335 NA high

Intervention Type DRUG

BI 201335 NA high

BI 201335 NA high placebo

Intervention Type DRUG

placebo

BI 201335 NA high TE

patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-experienced (TE) patients

Group Type EXPERIMENTAL

pegylated interferon (PegIFN) alfa-2a

Intervention Type DRUG

pegylated interferon (PegIFN) alfa-2a

ribavirin (RBV)

Intervention Type DRUG

ribavirin (RBV)

BI 201335 NA high

Intervention Type DRUG

BI 201335 NA high

Placebo in Treatment Naive (TN) Patients

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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ribavirin (RBV)

ribavirin (RBV)

Intervention Type DRUG

pegylated interferon (PegIFN) alfa-2a

pegylated interferon (PegIFN) alfa-2a

Intervention Type DRUG

pegylated interferon (PegIFN) alfa-2a

pegylated interferon (PegIFN) alfa-2a

Intervention Type DRUG

ribavirin (RBV)

ribavirin (RBV)

Intervention Type DRUG

BI 201335 NA low placebo

Placebo

Intervention Type DRUG

pegylated interferon (PegIFN) alfa-2a

pegylated interferon (PegIFN) alfa-2a

Intervention Type DRUG

ribavirin (RBV)

ribavirin (RBV)

Intervention Type DRUG

BI 201335 NA high

BI 201335 NA high

Intervention Type DRUG

BI 201335 NA low

BI 201335 NA

Intervention Type DRUG

BI 201335 NA high placebo

placebo

Intervention Type DRUG

BI 201335 NA high

BI 201335 NA high

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1220.14.003 Boehringer Ingelheim Investigational Site

Kurashiki, Okayama, , Japan

Site Status

1220.14.001 Boehringer Ingelheim Investigational Site

Minato-ku, Tokyo, , Japan

Site Status

1220.14.002 Boehringer Ingelheim Investigational Site

Nishinomiya, Hyogo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1220.14

Identifier Type: -

Identifier Source: org_study_id

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