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 2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01297270
First received: February 15, 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: BI201335
Drug: PegIFN/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
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
Faldaprevir 120mg and PegIFN/RBV Faldaprevir (BI 201335) 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240mg and PegIFN/RBV Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo and PegIFN/RBV Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.

Participant Flow:   Overall Study
    Faldaprevir 120mg and PegIFN/RBV     Faldaprevir 240mg and PegIFN/RBV     Placebo and PegIFN/RBV  
STARTED     262     264     132  
COMPLETED     217     192     103  
NOT COMPLETED     45     72     29  
Adverse Event                 19                 32                 5  
Lack of Efficacy                 15                 17                 15  
Lost to Follow-up                 1                 2                 1  
Protocol Violation                 0                 2                 0  
Withdrawal by Subject                 7                 15                 7  
Other reason not defined above                 3                 3                 1  
Not treated                 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) 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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240mg and PegIFN/RBV Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo and PegIFN/RBV Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Total Total of all reporting groups

Baseline Measures
    Faldaprevir 120mg and PegIFN/RBV     Faldaprevir 240mg and PegIFN/RBV     Placebo and PegIFN/RBV     Total  
Number of Participants  
[units: participants]
  262     263     132     657  
Age  
[units: years]
Mean (Standard Deviation)
  50.2  (10.05)     50.4  (9.40)     50.2  (8.78)     50.3  (9.53)  
Gender  
[units: participants]
       
Female     105     109     54     268  
Male     157     154     78     389  



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

2.  Secondary:   Sustained Virologic 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:   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:   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:   ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

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

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

11.  Secondary:   AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, 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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01297270     History of Changes
Other Study ID Numbers: 1220.47
2010-021716-42 ( EudraCT Number: EudraCT )
Study First Received: February 15, 2011
Results First Received: July 3, 2015
Last Updated: August 18, 2015
Health Authority: Canada: Health Canada
South Korea: Ministry of Food and Drug Safety (MFDS)
Taiwan : Food and Drug Administration
United States: Food and Drug Administration