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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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: July 21, 2009
Last updated: July 10, 2014
Last verified: July 2014

The safety, pharmacokinetics, and antiviral activity of BI 201335 NA in combination with pegylated interferon (PegIFN) alfa-2a and ribavirin (RBV) for 4 weeks in treatment-naïve patients and treatment-experienced patients both with genotype 1 hepatitis C virus (HCV) infection.

Condition Intervention Phase
Hepatitis C
Drug: BI 201335 llow placebo
Drug: BI 201335 low
Drug: BI 201335 high
Drug: BI 201335 high placebo
Drug: BI201335 high
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 Interferona-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 ]
  • Week 2 virological response (W2VR) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Week 4 virological response (W4VR) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Rapid virological response (RVR) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HCV viral load [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Day 28 virologic response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Early virological response (EVR) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Complete early virological response (cEVR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • End of treatment response (ETR) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Sustained virologic response (SVR) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters after the first dose: Cmax, tmax, AUCτ,1 (BI 201335 ZW and RBV) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Trough concentration (BI 201335 ZW, RBV and Peg-IFNα2a) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters at steady state: Cmax,ss, tmax,ss, Cmin,ss, AUCτ,ss, CL/Fss, Cavg (BI 201335 ZW and RBV) [ Time Frame: 4 week ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters at steady state: λz,ss, t1/2,ss, MRTpo,ss, Vz/F,ss (only BI 201335 ZW if possible) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters at steady state: C72,ss (Peg-IFNα2a only) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: July 2009
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 TN patients
Drug: BI 201335 llow placebo
Placebo with IFN/RBV
Drug: BI 201335 low
BI 201335 with IFN/RBV
Experimental: BI 201335 NA high TN
patient to receive a capsule containing high dose of BI 201335 NA/Drug for TN patients
Drug: BI 201335 high
BI 201335 high with IFN/RBV
Drug: BI 201335 high placebo
placebo with IFN/RBV
Experimental: BI 201335 NA high TE
patient to receive a capsule containing high dose of BI 201335 NA/Drug for TE patients
Drug: BI201335 high
BI 201335 high with IFN/RBV


Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00947349

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
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT00947349     History of Changes
Other Study ID Numbers: 1220.14
Study First Received: July 21, 2009
Last Updated: July 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on November 23, 2014