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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.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00947349
First received: July 21, 2009
Last updated: July 3, 2015
Last verified: July 2015
Results First Received: January 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Conditions: Hepatitis C
Pharmacokinetics
Interventions: 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
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo in Treatment Naive (TN) Patients Matching placebo to BI 201335 (Faldaprevir) NA (sodium) with PegIFN/RBV in TN patients
BI 201335 NA Low for Treatment Naive (TN) Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d. (once daily)) with PegIFN/RBV in treatment naive (TN) patients
BI 201335 NA High TN Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
BI 201335 NA High for Treatment Experienced (TE) Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in treatment experienced (TE) patients.

Participant Flow for 2 periods

Period 1:   Triple Treatment Combination Period
    Placebo in Treatment Naive (TN) Patients     BI 201335 NA Low for Treatment Naive (TN)     BI 201335 NA High TN     BI 201335 NA High for Treatment Experienced (TE)  
STARTED     4     6     6     6  
COMPLETED     4     5     6     6  
NOT COMPLETED     0     1     0     0  
Adverse Event                 0                 1                 0                 0  

Period 2:   Overall Study Standard of Care
    Placebo in Treatment Naive (TN) Patients     BI 201335 NA Low for Treatment Naive (TN)     BI 201335 NA High TN     BI 201335 NA High for Treatment Experienced (TE)  
STARTED     4     5     6     6  
COMPLETED     4     5     4     4  
NOT COMPLETED     0     0     2     2  
Lack of Efficacy                 0                 0                 1                 1  
Withdrawal by Subject                 0                 0                 1                 0  
not specified                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.

Reporting Groups
  Description
Placebo in TN Patients Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
BI 201335 NA Low TN Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
BI 201335 NA High TN Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.). with PegIFN/RBV in TN patients
BI 201335 NA High TE Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
Total Total of all reporting groups

Baseline Measures
    Placebo in TN Patients     BI 201335 NA Low TN     BI 201335 NA High TN     BI 201335 NA High TE     Total  
Number of Participants  
[units: participants]
  4     6     6     6     22  
Age  
[units: years]
Mean (Standard Deviation)
  53.5  (6.0)     48.0  (13.5)     56.0  (9.2)     58.0  (8.3)     53.9  (10.1)  
Gender  
[units: participants]
         
Female     1     4     4     0     9  
Male     3     2     2     6     13  



  Outcome Measures
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1.  Primary:   Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy   [ Time Frame: 4 weeks ]

2.  Primary:   Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy   [ Time Frame: 4 weeks ]

3.  Primary:   Assessment of Tolerability in Triple Combination Therapy   [ Time Frame: 4 weeks ]

4.  Secondary:   Week 2 Virological Response (W2VR)   [ Time Frame: 2 weeks ]

5.  Secondary:   Week 4 Virological Response (W4VR)   [ Time Frame: 4 weeks ]

6.  Secondary:   Rapid Virological Response (RVR)   [ Time Frame: 4 weeks ]

7.  Secondary:   Change From Baseline in HCV Viral Load   [ Time Frame: baseline and week 4 ]

8.  Secondary:   Day 28 Virologic Response   [ Time Frame: 4 weeks ]

9.  Secondary:   Early Virological Response (EVR)   [ Time Frame: 12 Weeks ]

10.  Secondary:   Complete Early Virological Response (cEVR)   [ Time Frame: 12 weeks ]

11.  Secondary:   End of Treatment Response (ETR)   [ Time Frame: 48 weeks ]

12.  Secondary:   Sustained Virologic Response (SVR)   [ Time Frame: 72 weeks ]

13.  Secondary:   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 ]

14.  Secondary:   Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV   [ Time Frame: 44 weeks ]

15.  Secondary:   Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV   [ Time Frame: 44 weeks ]

16.  Secondary:   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 ]

17.  Secondary:   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 ]

18.  Secondary:   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 ]

19.  Secondary:   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 ]

20.  Secondary:   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 ]

21.  Secondary:   Cmax of RBV   [ Time Frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose ]

22.  Secondary:   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 ]

23.  Secondary:   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 ]

24.  Secondary:   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 ]

25.  Secondary:   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 ]

26.  Secondary:   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 ]

27.  Secondary:   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 ]

28.  Secondary:   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 ]

29.  Secondary:   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 ]

30.  Secondary:   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 ]

31.  Secondary:   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 ]

32.  Secondary:   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 ]

33.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab “Full Text Review”, section “More Information".


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00947349     History of Changes
Other Study ID Numbers: 1220.14
Study First Received: July 21, 2009
Results First Received: January 22, 2015
Last Updated: July 3, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency