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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  
Number of Participants  
[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
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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