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OpenTrials
Completed

NCT Number: NCT00947349

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients

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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Pharmacokinetics RNA Virus Infections Virus Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1220.14.003 Boehringer Ingelheim Investigational Site, Kurashiki, Okayama, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ribavirin (RBV)

Drug

ribavirin (RBV)

pegylated interferon (PegIFN) alfa-2a

Drug

pegylated interferon (PegIFN) alfa-2a

BI 201335 NA low placebo

Drug

Placebo

BI 201335 NA high

Drug

BI 201335 NA high

BI 201335 NA low

Drug

BI 201335 NA

BI 201335 NA high placebo

Drug

placebo

Placebo

Drug

Primary outcomes

  1. Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy

    Time frame: 4 weeks

    Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.

  2. Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy

    Time frame: 4 weeks

    Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.

  3. Assessment of Tolerability in Triple Combination Therapy

    Time frame: 4 weeks

    An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.

Secondary outcomes

  1. Week 2 Virological Response (W2VR)

    Time frame: 2 weeks

    Number of patients satisfying W2VR (plasma HCV RNA (Hepatitis C Virus Ribonucleic acid) level below the limit of quantification (BLQ))

  2. Week 4 Virological Response (W4VR)

    Time frame: 4 weeks

    Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ))

  3. Rapid Virological Response (RVR)

    Time frame: 4 weeks

    Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4)

  4. Change From Baseline in HCV Viral Load

    Time frame: baseline and week 4

    Change form baseline in HCV viral load (log10) after 4 weeks

  5. Day 28 Virologic Response

    Time frame: 4 weeks

    Number of patients with HCV viral load reduction >= 2 log10 at Week 4

  6. Early Virological Response (EVR)

    Time frame: 12 Weeks

    Number of patients with reduction >= 2 log10 in plasma HCV RNA level at Week 12

  7. Complete Early Virological Response (cEVR)

    Time frame: 12 weeks

    Number of patients with plasma HCV RNA level BLD at Week 12

  8. End of Treatment Response (ETR)

    Time frame: 48 weeks

    Number of patients with plasma HCV RNA level BLD at week 48

  9. Sustained Virologic Response (SVR)

    Time frame: 72 weeks

    Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion

  10. Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV

    Time frame: 44 weeks

    Drug-related AEs in SOC treatment period were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.

  11. Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV

    Time frame: 44 weeks

    Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in SOC period for treatment naive patients and treatment experienced patients.

  12. Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV

    Time frame: 44 weeks

    An assessment of tolerability for the safety of the SOC with PegIFN alfa-2a and RBV.

  13. AUCτ,1 for BI 201335 ZW

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose

    Area under the curve (AUC) concentration after the first dose of BI 201335 ZW

  14. Cmax of BI 201335 ZW

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose

    Maximum concentration of BI 201335 ZW after multiple oral admin. of BI 201335 NA with RBV and PegIFN alfa-2a

  15. AUCτ,ss of BI 201335 ZW

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

    AUC at steady state after 4 weeks combination of the last dose

  16. Cmax,ss of BI 201335 ZW

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

    Maximum concentration of BI 201335 ZW at steady state

  17. AUCτ,1 for Ribavirin (RBV)

    Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose

    Area under the plasma concentration curve of RBV after the first dose of placebo or BI 201335 NA with with RBV and PegIFN alfa-2a

  18. Cmax of RBV

    Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose

    Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a

  19. AUCτ,ss of RBV

    Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose

    Area under the plasma concentration curve of RBV after the multiple oral administration of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state

  20. Cmax,ss of RBV

    Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose

    Maximum Plasma concentration of RBV after multiple oral admin. of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state

  21. Tmax for BI 201335 ZW

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose

    Time to maximum plasma concentration (tmax) of BI 201335 ZW after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a

  22. Tmax for RBV

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose

    Time to maximum plasma concentration (tmax) of RBV after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a

  23. Tmax, ss for BI 201335 ZW

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

    Time from last dosing to the maximum plasma concentration (tmax) of BI 201335 ZW after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state

  24. Tmax, ss for RBV

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

    Time to the maximum plasma concentration (tmax) of RBV after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state

  25. t1/2,ss for BI 201335 ZW

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

    terminal half-life of the analyte in plasma at steady state (t1/2,ss)

  26. Cmin,ss for BI 201335 ZW

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

    Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state

  27. Cmin,ss for RBV

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

    Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state

  28. Cavg for BI 201335 ZW

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

    average plasma concentration (Cavg) of BI 201335 ZW

  29. Cavg for RBV

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

    average plasma concentration (Cavg) of RBV

  30. CL/F,ss for BI 201335 ZW

    Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

    apparent clearance of the analyte (BI 201335 ZW) in plasma at steady state (CL/F,ss) following multiple oral administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 28, 2009
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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