A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01330316
First received: April 5, 2011
Last updated: July 3, 2015
Last verified: July 2015
Results First Received: July 3, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: BI 201335
Drug: PegIFN/RBV

  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
This was a multi-national, open-label trial enrolling two cohorts of patients with chronic Hepatitis C Virus (HCV) infection of genotype 1 (GT-1) who were randomized to the placebo arm (+ Pegylated interferon α-2a/ Ribavirin) and experienced virologic failure in one of the 1220.7 (NCT01358864), 1220.30 (NCT01343888), 1220.47 (NCT01297270) trials.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible patients who entered the rollover trial within 14 weeks of their last study visit in one of the predecessor trials were not required to do a screening visit (treatment start: Day 1). Eligible patients who were outside of this 14-week window were required to do a screening visit (Visit 1) and started treatment at Visit 2 (Day 1).

Reporting Groups
  Description
Relapse

Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients.

At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV.

ETS is defined as Hepatitis C virus(HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8. Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser.

Non-relapse

Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients.

Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10 decrease in HCV RNA from baseline during the treatment period.

Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA. Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment.


Participant Flow:   Overall Study
    Relapse     Non-relapse  
STARTED     43     75  
COMPLETED     41     60  
NOT COMPLETED     2     15  
Adverse Event                 2                 2  
Lack of Efficacy                 0                 10  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 0                 1  
other than above                 0                 1  



  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): This set included all patients who entered the trial, were dispensed study medication, and were documented to have taken at least one dose of study medication.

Reporting Groups
  Description
Relapse FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
Non-relapse FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Total Total of all reporting groups

Baseline Measures
    Relapse     Non-relapse     Total  
Number of Participants  
[units: participants]
  43     75     118  
Age  
[units: years]
Mean (Standard Deviation)
  55.4  (7.38)     53.4  (9.46)     54.1  (8.78)  
Gender  
[units: participants]
     
Female     16     25     41  
Male     27     50     77  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL   [ Time Frame: 12 weeks post treatment, up to 60 weeks ]

2.  Secondary:   Sustained 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:   Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT)   [ Time Frame: Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers ]

5.  Secondary:   Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.   [ Time Frame: 48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS ]

6.  Secondary:   Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)   [ Time Frame: Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers. ]

7.  Secondary:   Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment.   [ Time Frame: Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers ]

8.  Secondary:   Occurrence of Adverse Events (Overall and by DAIDS Grade)   [ Time Frame: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days ]

9.  Secondary:   Occurrence of Adverse Events Leading to Treatment Discontinuation   [ Time Frame: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days ]

10.  Secondary:   Occurrence of Serious Adverse Events (SAEs)   [ Time Frame: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days ]

11.  Secondary:   Occurrence of Drug-related AEs as Assessed by the Investigator   [ Time Frame: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days ]

12.  Secondary:   Laboratory Test Abnormalities by DAIDS Grades   [ Time Frame: baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study ]

13.  Secondary:   Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin]   [ Time Frame: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) ]

14.  Secondary:   Changes From Baseline in Laboratory Test Values Over Time [ALT]   [ Time Frame: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) ]

15.  Secondary:   Changes From Baseline in Laboratory Test Values Over Time [AST]   [ Time Frame: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) ]

16.  Secondary:   Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]   [ Time Frame: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment) ]


  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


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01330316     History of Changes
Other Study ID Numbers: 1220.48, 2011-000141-20
Study First Received: April 5, 2011
Results First Received: July 3, 2015
Last Updated: July 3, 2015
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
France: Agence Nationale sécurité médicament et des produits santé
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
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration