Clinical Trial Results:
Voriconazole in High-Risk Patients With Invasive Fungal Infections in Slovakia. An Open, Prospective, Non-Comparative Study. (Ve-RIFI)
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Summary
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EudraCT number |
2017-000501-20 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
16 Nov 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Jun 2017
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First version publication date |
09 Jun 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
A1501082
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01137292 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Pfizer, Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Apr 2010
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Nov 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To collect data on treatment outcomes (clinical and mycological cure), safety and tolerability of treatment with voriconazole in subjects with invasive fungal infections in Slovakia.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Apr 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Slovakia: 177
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Worldwide total number of subjects |
177
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EEA total number of subjects |
177
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
3
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Children (2-11 years) |
8
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Adolescents (12-17 years) |
6
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Adults (18-64 years) |
134
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From 65 to 84 years |
26
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
The study was conducted from 12 April 2007 to 16 November 2009 in Slovakia. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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Voriconazole | ||||||||||||||||||
Arm description |
Subjects received Voriconazole intravenously at a loading dose of 6 milligram per kilogram (mg/kg) every 12 hours (during the first 24 hours) followed by the maintenance dose of 4 mg/kg twice daily up to 2 weeks. Subjects weighing greater than (>) 40 kg, received oral formulation at a loading dose of 400 mg twice during the first 24 hours followed by maintenance dose of 200 mg twice daily up to 2 weeks. Subjects weighing less than (<) 40 kg received oral formulation at a loading dose of 200 mg twice during the first 24 hours followed by maintenance dose of 100 mg twice daily up to 2 weeks. Paediatric subjects <12 years received 7 mg/kg intravenously or 200 mg orally twice daily up to 2 weeks. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Voriconazole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subjects received Voriconazole at a loading dose of 6 mg/kg every 12 hours (during the first 24 hours) followed by the maintenance dose of 4 mg/kg twice daily up to 2 weeks. Paediatric subjects <12 years received 7 mg/kg or 200 mg twice daily up to 2 weeks.
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Investigational medicinal product name |
Voriconazole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects weighing >40 kg, received formulation at a loading dose of 400 mg twice during the first 24 hours followed by maintenance dose of 200 mg twice daily up to 2 weeks. Subjects weighing <40 kg received formulation at a loading dose of 200 mg twice during the first 24 hours followed by maintenance dose of 100 mg twice daily up to 2 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Voriconazole
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Reporting group description |
Subjects received Voriconazole intravenously at a loading dose of 6 milligram per kilogram (mg/kg) every 12 hours (during the first 24 hours) followed by the maintenance dose of 4 mg/kg twice daily up to 2 weeks. Subjects weighing greater than (>) 40 kg, received oral formulation at a loading dose of 400 mg twice during the first 24 hours followed by maintenance dose of 200 mg twice daily up to 2 weeks. Subjects weighing less than (<) 40 kg received oral formulation at a loading dose of 200 mg twice during the first 24 hours followed by maintenance dose of 100 mg twice daily up to 2 weeks. Paediatric subjects <12 years received 7 mg/kg intravenously or 200 mg orally twice daily up to 2 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Voriconazole
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Reporting group description |
Subjects received Voriconazole intravenously at a loading dose of 6 milligram per kilogram (mg/kg) every 12 hours (during the first 24 hours) followed by the maintenance dose of 4 mg/kg twice daily up to 2 weeks. Subjects weighing greater than (>) 40 kg, received oral formulation at a loading dose of 400 mg twice during the first 24 hours followed by maintenance dose of 200 mg twice daily up to 2 weeks. Subjects weighing less than (<) 40 kg received oral formulation at a loading dose of 200 mg twice during the first 24 hours followed by maintenance dose of 100 mg twice daily up to 2 weeks. Paediatric subjects <12 years received 7 mg/kg intravenously or 200 mg orally twice daily up to 2 weeks. | ||
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End point title |
Number of Subjects With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit [1] | ||||||||||||||||||
End point description |
Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure and no mycological culture performed. Subjects could have more than one responses. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines. Full analysis set (FAS) included all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy available.
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End point type |
Primary
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End point timeframe |
Baseline up to 2 Weeks (EOT visit)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned to be analysed in this end point. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Subjects With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit [2] | ||||||||||||||||||||||
End point description |
Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Subjects could have more than one responses. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines. FAS included all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy available.
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End point type |
Primary
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End point timeframe |
6 weeks after last dose of study drug
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned to be analysed in this end point. |
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Number of Subjects With Investigator's Satisfaction with the Efficacy of Voriconazole Assessment at the End of Treatment (EOT) Visit [3] | ||||||||||||||
End point description |
Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement. FAS included all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy available. Here, 'number of subjects analyzed' signifies the subjects who were evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Baseline up to 2 weeks (EOT visit)
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned to be analysed in this end point. |
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Number of Subjects With Investigator's Satisfaction with the Tolerability of Voriconazole Assessment at the End of Treatment (EOT) Visit [4] | ||||||||||||||
End point description |
Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement. Safety population included subjects who received at least 1 dose of the study medication. Here, 'number of subjects analyzed' signifies the subjects who were evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Baseline up to 2 weeks (EOT visit)
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned to be analysed in this end point. |
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| No statistical analyses for this end point | |||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to 28 days after the last dose of study drug
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Adverse event reporting additional description |
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.1
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Reporting groups
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Reporting group title |
Voriconazole
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Reporting group description |
Subjects received Voriconazole intravenously at a loading dose of 6 milligram per kilogram (mg/kg) every 12 hours (during the first 24 hours) followed by the maintenance dose of 4 mg/kg twice daily up to 2 weeks. Subjects weighing greater than (>) 40 kg, received oral formulation at a loading dose of 400 mg twice during the first 24 hours followed by maintenance dose of 200 mg twice daily up to 2 weeks. Subjects weighing less than (<) 40 kg received oral formulation at a loading dose of 200 mg twice during the first 24 hours followed by maintenance dose of 100 mg twice daily up to 2 weeks. Paediatric subjects <12 years received 7 mg/kg intravenously or 200 mg orally twice daily up to 2 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
