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Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01358864
First received: May 23, 2011
Last updated: July 28, 2016
Last verified: July 2016
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 (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: BI 201335
Drug: Pegylated Interferon-alpha (IFN)
Drug: Ribavirin (RBV)
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
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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
Relapser:Placebo Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Relapser:Faldaprevir 12 Weeks Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Relapser:Faldaprevir 24 Weeks Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Partial:Placebo Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Partial:Faldaprevir 12 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Partial:Faldaprevir 24 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Null:Faldaprevir 12 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Null:Faldaprevir 24 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.

Participant Flow:   Overall Study
    Relapser:Placebo   Relapser:Faldaprevir 12 Weeks   Relapser:Faldaprevir 24 Weeks   Partial:Placebo   Partial:Faldaprevir 12 Weeks   Partial:Faldaprevir 24 Weeks   Null:Faldaprevir 12 Weeks   Null:Faldaprevir 24 Weeks
STARTED   49   99   103   29   57   55   146   140 
COMPLETED   18   86   87   10   46   42   81   85 
NOT COMPLETED   31   13   16   19   11   13   65   55 
Adverse Event                0                6                9                0                4                8                12                7 
Lack of Efficacy                26                3                4                19                7                4                49                44 
Lost to Follow-up                0                0                1                0                0                0                0                1 
Withdrawal by Subject                3                4                2                0                0                1                1                3 
Other reason not defined above                2                0                0                0                0                0                2                0 
Not treated                0                0                0                0                0                0                1                0 



  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)

Reporting Groups
  Description
Relapser:Placebo Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Relapser:Faldaprevir 12 Weeks Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Relapser:Faldaprevir 24 Weeks Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Partial:Placebo Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Partial:Faldaprevir 12 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Partial:Faldaprevir 24 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Null:Faldaprevir 12 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Null:Faldaprevir 24 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Relapser:Placebo   Relapser:Faldaprevir 12 Weeks   Relapser:Faldaprevir 24 Weeks   Partial:Placebo   Partial:Faldaprevir 12 Weeks   Partial:Faldaprevir 24 Weeks   Null:Faldaprevir 12 Weeks   Null:Faldaprevir 24 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   99   103   29   57   55   145   140   677 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.4  (8.29)   53.5  (8.57)   53.7  (8.14)   55.7  (7.50)   52.7  (7.90)   52.0  (10.32)   53.2  (8.76)   53.6  (8.13)   53.4  (8.48) 
Gender 
[Units: Participants]
                 
Female   20   44   43   10   20   20   54   63   274 
Male   29   55   60   19   37   35   91   77   403 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sustained Virological Response 12 Weeks Post Treatment (SVR12)   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

2.  Secondary:   Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)   [ Time Frame: 24 weeks post treatment, up to 72 weeks ]

3.  Secondary:   Early Treatment Success (ETS)   [ Time Frame: Week 4 and Week 8 ]

4.  Secondary:   ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO   [ Time Frame: End of treatment, up to 48 weeks ]

5.  Secondary:   ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES   [ Time Frame: End of treatment, up to 48 weeks ]

6.  Secondary:   AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO   [ Time Frame: End of treatment, up to 48 weeks ]

7.  Secondary:   AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES   [ Time Frame: End of treatment, up to 48 weeks ]

8.  Secondary:   ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

9.  Secondary:   ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

10.  Secondary:   AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

11.  Secondary:   AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]


  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
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  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: NCT01358864     History of Changes
Other Study ID Numbers: 1220.7
2010-021715-17 ( EudraCT Number: EudraCT )
Study First Received: May 23, 2011
Results First Received: July 3, 2015
Last Updated: July 28, 2016
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Japan: Ministry of Health, Labor and Welfare
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration