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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01343888
First received: April 20, 2011
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
Interventions: Drug: PegIFN/RBV
Drug: BI 201335
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
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.

Reporting Groups
  Description
Faldaprevir 120mg and PegIFN/RBV Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48.
Faldaprevir 240mg and PegIFN/RBV Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48.
Placebo and PegIFN/RBV Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.

Participant Flow:   Overall Study
    Faldaprevir 120mg and PegIFN/RBV   Faldaprevir 240mg and PegIFN/RBV   Placebo and PegIFN/RBV
STARTED   259 [1]   261 [2]   132 [3] 
COMPLETED   234   222   110 
NOT COMPLETED   25   39   22 
Adverse Event                12                22                5 
Lack of Efficacy                9                9                13 
Lost to Follow-up                0                2                1 
Protocol Violation                0                2                0 
Withdrawal by Subject                4                4                2 
other than stated above                0                0                1 
[1] 261 subject randomized; 259 subjects treated with at least one dose; 2 subjects were not treated
[2] 262 subject randomized; 261 subjects treated with at least one dose; 1 subject was not treated
[3] 133 subject randomized; 132 subjects treated with at least one dose; 1 subject was not treated



  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) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose.

Reporting Groups
  Description
Faldaprevir 120mg and PegIFN/RBV Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240mg and PegIFN/RBV Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo and PegIFN/RBV Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Total Total of all reporting groups

Baseline Measures
   Faldaprevir 120mg and PegIFN/RBV   Faldaprevir 240mg and PegIFN/RBV   Placebo and PegIFN/RBV   Total 
Overall Participants Analyzed 
[Units: Participants]
 259   261   132   652 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.9  (11.44)   48.3  (11.89)   46.6  (12.53)   47.8  (11.85) 
Gender 
[Units: Participants]
       
Female   138   115   57   310 
Male   121   146   75   342 


  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:   Sustained Virological Response 24 Weeks Post-treatment (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:   Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

5.  Secondary:   Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

6.  Secondary:   Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

7.  Secondary:   Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

8.  Secondary:   Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

9.  Secondary:   Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

10.  Secondary:   Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

11.  Secondary:   Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO   [ 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


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01343888     History of Changes
Other Study ID Numbers: 1220.30
2010-021716-42 ( EudraCT Number: EudraCT )
Study First Received: April 20, 2011
Results First Received: July 3, 2015
Last Updated: August 18, 2015
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
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
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration