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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

NCT00947349 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-07-07

Study results available
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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

Conditions

  • Hepatitis C
  • Pharmacokinetics

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Japan

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00947349 on ClinicalTrials.gov