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

July 21, 2009
July 10, 2014
July 2009
August 2011   (final data collection date for primary outcome measure)
  • 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 ]
There is no primary endpoint of efficacy in this trial. Instead, safety for the triple combination therapy will be assessed based on: 1. Adverse Events 2. Laboratory test abnormalities 3. Laboratory test value changes over time 4. Tolerability [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT00947349 on ClinicalTrials.gov Archive Site
  • 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 ]
Loss of virological response at week 4, 12, 24, 48 and 72 [ Time Frame: 72 weeks ]
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Hepatitis C
  • Pharmacokinetics
  • Drug: BI 201335 llow placebo
    Placebo with IFN/RBV
  • Drug: BI 201335 low
    BI 201335 with IFN/RBV
  • Drug: BI 201335 high
    BI 201335 high with IFN/RBV
  • Drug: BI 201335 high placebo
    placebo with IFN/RBV
  • Drug: BI201335 high
    BI 201335 high with IFN/RBV
  • Experimental: BI 201335 NA low TN
    patient to receive a capsule containing low dose of BI 201335 NA/Drug for TN patients
    Interventions:
    • Drug: BI 201335 llow placebo
    • Drug: BI 201335 low
  • Experimental: BI 201335 NA high TN
    patient to receive a capsule containing high dose of BI 201335 NA/Drug for TN patients
    Interventions:
    • Drug: BI 201335 high
    • Drug: BI 201335 high placebo
  • Experimental: BI 201335 NA high TE
    patient to receive a capsule containing high dose of BI 201335 NA/Drug for TE patients
    Intervention: Drug: BI201335 high
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
Not Provided
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00947349
1220.14
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP