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: July 10, 2014
Last verified: July 2014
  Purpose

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
Pharmacokinetics
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

  Eligibility

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

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
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: July 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 18, 2014