Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00793793
First received: September 23, 2008
Last updated: August 18, 2015
Last verified: August 2015
Results First Received: July 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: BI201335
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
Treatment Naive (TN): Placebo TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
Treatment Naive(TN): 20mg Per Day (QD) TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
TN: 48mg QD TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN: 120mg QD TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN: 240mg QD TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE Non-cirrhotic: 120 mg QD TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE Non-cirrhotic: 240 mg QD TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE With Cirrhosis: 240 mg QD SGC TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE With Cirrhosis: 240 mg BID SGC TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days

Participant Flow:   Overall Study
    Treatment Naive (TN): Placebo     Treatment Naive(TN): 20mg Per Day (QD)     TN: 48mg QD     TN: 120mg QD     TN: 240mg QD     Treatment Experienced (TE) Non-cirrhotic: 48 mg QD     TE Non-cirrhotic: 120 mg QD     TE Non-cirrhotic: 240 mg QD     TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)     TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC     TE With Cirrhosis: 240 mg QD SGC     TE With Cirrhosis: 240 mg BID SGC  
STARTED     8     6     7     7     6     6     7     6     15     15     6     7  
COMPLETED     8     5     5     4     4     4     3     6     6     6     3     1  
NOT COMPLETED     0     1     2     3     2     2     4     0     9     9     3     6  
Adverse Event                 0                 0                 1                 1                 0                 1                 2                 0                 0                 0                 0                 2  
Protocol Violation                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0  
Lost to Follow-up                 0                 0                 1                 0                 0                 0                 0                 0                 1                 3                 1                 0  
Withdrawal by Subject                 0                 0                 0                 0                 1                 0                 0                 0                 1                 0                 0                 0  
reason not specified                 0                 1                 0                 1                 1                 1                 2                 0                 7                 6                 2                 4  



  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.
Full Analysis Set (FAS): All randomized patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.

Reporting Groups
  Description
Treatment Naive (TN): Placebo TN patient to receive Placebo + PegIFN/RBV for 28 days
TN: 20mg QD TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN: 48mg QD TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN: 120mg QD TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN: 240mg QD TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE Non-cirrhotic: 120 mg QD TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE Non-cirrhotic: 240 mg QD TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE Non-cirrhotic: 240 mg BID SGC TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE With Cirrhosis: 240 mg QD SGC TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE With Cirrhosis: 240 mg BID SGC TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Total Total of all reporting groups

Baseline Measures
    Treatment Naive (TN): Placebo     TN: 20mg QD     TN: 48mg QD     TN: 120mg QD     TN: 240mg QD     Treatment Experienced (TE) Non-cirrhotic: 48 mg QD     TE Non-cirrhotic: 120 mg QD     TE Non-cirrhotic: 240 mg QD     TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)     TE Non-cirrhotic: 240 mg BID SGC     TE With Cirrhosis: 240 mg QD SGC     TE With Cirrhosis: 240 mg BID SGC     Total  
Number of Participants  
[units: participants]
  8     6     7     7     6     6     7     6     15     15     6     7     96  
Age  
[units: years]
Mean (Standard Deviation)
  49.88  (8.36)     51.00  (7.97)     47.14  (13.84)     48.57  (16.31)     47.83  (9.26)     46.83  (11.82)     46.71  (4.79)     49.33  (10.11)     50.93  (8.13)     48.93  (13.10)     53.67  (5.32)     53.57  (8.36)     49.59  (10.08)  
Gender  
[units: participants]
                         
Female     2     0     2     2     1     2     3     3     5     7     1     2     30  
Male     6     6     5     5     5     4     4     3     10     8     5     5     66  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)   [ Time Frame: Baseline and up to 4 weeks ]

2.  Primary:   Occurrence of Adverse Events (AEs) During BI201335 + Washout Period   [ Time Frame: from day 1 and up to 4 weeks + 4 days washout ]

3.  Primary:   Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period   [ Time Frame: from day 1 and up to 4 weeks + 4 days washout ]

4.  Primary:   Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time   [ Time Frame: Baseline and up to 4 weeks ]

5.  Secondary:   Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients   [ Time Frame: Baseline and up to 4 weeks ]

6.  Secondary:   Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients   [ Time Frame: Baseline and up to 4 weeks ]

7.  Secondary:   Rapid Virologic Response (RVR)   [ Time Frame: week 4 ]

8.  Secondary:   Early Virologic Response (EVR)   [ Time Frame: week 12 ]

9.  Secondary:   Complete EVR1 (cEVR1)   [ Time Frame: week 4 and week 12 ]

10.  Secondary:   Complete EVR2 (cEVR2)   [ Time Frame: week 4 and week 12 ]

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

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

13.  Secondary:   Achievement of an HCV RNA Level Below the Limit of Detection Over Time   [ Time Frame: from day 1 and up to 4 weeks ]

14.  Secondary:   Achievement of an HCV RNA Level Below the Limit of Quantification Over Time   [ Time Frame: from day 1 and up to 4 weeks ]

15.  Secondary:   Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time   [ Time Frame: from day 1 and up to 4 weeks ]

16.  Secondary:   Occurrence of AEs, by Action Taken With Regard to Study Medication   [ Time Frame: from day 1 and up to 4 weeks ]

17.  Secondary:   Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period   [ Time Frame: from day 1 and up to 4 weeks ]

18.  Secondary:   PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)   [ Time Frame: Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1) ]

19.  Secondary:   PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)   [ Time Frame: Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1) ]

20.  Secondary:   PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)   [ Time Frame: Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1) ]

21.  Secondary:   PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28) ]

22.  Secondary:   PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28) ]

23.  Secondary:   PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28) ]

24.  Secondary:   PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28) ]

25.  Secondary:   PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28) ]

26.  Secondary:   PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28) ]

27.  Secondary:   PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28) ]

28.  Secondary:   PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28) ]

29.  Secondary:   PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14) ]

30.  Secondary:   PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14) ]

31.  Secondary:   PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss   [ Time Frame: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14) ]

32.  Secondary:   Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax   [ Time Frame: Day 1, Day 14, and Day 28 ]

33.  Secondary:   Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc   [ Time Frame: Day 1, Day 14, and Day 28 ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00793793     History of Changes
Other Study ID Numbers: 1220.2
2007-001158-19 ( EudraCT Number: EudraCT )
Study First Received: September 23, 2008
Results First Received: July 3, 2015
Last Updated: August 18, 2015
Health Authority: France: AFSSAPS
Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medical Devices)
Spain: Spanish Agency for Medicines and Health Products
United States: Food and Drug Administration