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
ClinicalTrials.gov Identifier:
NCT00947349
First received: July 21, 2009
Last updated: December 22, 2014
Last verified: December 2014
  Purpose

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


Condition Intervention Phase
Hepatitis C
Pharmacokinetics
Drug: ribavirin (RBV)
Drug: pegylated interferon (PegIFN) alfa-2a
Drug: BI 201335 NA low placebo
Drug: BI 201335 NA high
Drug: BI 201335 NA low
Drug: BI 201335 NA high placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: July 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 201335 NA low TN
patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients
Drug: pegylated interferon (PegIFN) alfa-2a
pegylated interferon (PegIFN) alfa-2a
Drug: BI 201335 NA low placebo
Placebo
Drug: ribavirin (RBV)
ribavirin (RBV)
Drug: BI 201335 NA low
BI 201335 NA
Experimental: BI 201335 NA high TN
patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients
Drug: ribavirin (RBV)
ribavirin (RBV)
Drug: pegylated interferon (PegIFN) alfa-2a
pegylated interferon (PegIFN) alfa-2a
Drug: BI 201335 NA high
BI 201335 NA high
Drug: BI 201335 NA high placebo
placebo
Experimental: BI 201335 NA high TE
patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-experienced (TE) patients
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947349

Locations
Japan
1220.14.003 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
1220.14.001 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan
1220.14.002 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00947349     History of Changes
Other Study ID Numbers: 1220.14
Study First Received: July 21, 2009
Last Updated: December 22, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Interferons
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 26, 2015