Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01399619
First received: July 20, 2011
Last updated: August 6, 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: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: PegIFN/RBV
Drug: BI201335
Drug: BI201335 24W
Drug: Bi 201335

  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
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Reporting Groups
  Description
Faldaprevir 120mg -24W Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg -12W Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-24W Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg -NR (Prior to Re-randomization at Week 12) Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12.

Participant Flow:   Overall Study
    Faldaprevir 120mg -24W     Faldaprevir 240mg -12W     Faldaprevir 240mg-24W     Faldaprevir 240 mg -NR (Prior to Re-randomization at Week 12)  
STARTED     123     84     86     17  
COMPLETED     98     84     74     0  
NOT COMPLETED     25     0     12     17  
Adverse Event                 10                 0                 4                 10  
Lack of Efficacy                 9                 0                 5                 0  
Withdrawal by Subject                 6                 0                 3                 4  
Protocol Violation                 0                 0                 0                 1  
Not treated                 0                 0                 0                 2  



  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.
FAS (All patients who were randomized and received at least one dose of assigned therapy)

Reporting Groups
  Description
Faldaprevir 120mg - 24W Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg -T patient to receive Faldaprevir 240 mg once a day for 12 or 24 weeks and PegIFN/RBV for 24 or 48 weeks + patients who received Faldaprevir 240 mg and discontinued prior to week 12.
Total Total of all reporting groups

Baseline Measures
    Faldaprevir 120mg - 24W     Faldaprevir 240mg -T     Total  
Number of Participants  
[units: participants]
  123     185     308  
Age  
[units: years]
Mean (Standard Deviation)
  47.6  (7.63)     46.5  (8.36)     46.9  (8.08)  
Gender  
[units: participants]
     
Female     20     40     60  
Male     103     145     248  



  Outcome Measures
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1.  Primary:   Sustained Virological Response (SVR12)   [ Time Frame: 60 weeks ]

2.  Secondary:   Virological Response 24 Weeks Post Treatment (SVR24)   [ Time Frame: 72 weeks ]

3.  Secondary:   Early Treatment Success (ETS)   [ Time Frame: Week 4, week 8 and week 60 ]

4.  Secondary:   The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes   [ Time Frame: 48 weeks ]

5.  Secondary:   The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no   [ Time Frame: 48 weeks ]

6.  Secondary:   The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes   [ Time Frame: 60 weeks ]

7.  Secondary:   The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no   [ Time Frame: 60 weeks ]

8.  Secondary:   The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes   [ Time Frame: 48 weeks ]

9.  Secondary:   The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no   [ Time Frame: 48 weeks ]

10.  Secondary:   The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes   [ Time Frame: 60 weeks ]

11.  Secondary:   The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no   [ Time Frame: 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: NCT01399619     History of Changes
Other Study ID Numbers: 1220.19
2010-021734-59 ( EudraCT Number: EudraCT )
Study First Received: July 20, 2011
Results First Received: July 3, 2015
Last Updated: August 6, 2015
Health Authority: Brazil: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration