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Evaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO

Last updated on November 13, 2019

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Study Location
Istituto di Ematologia
Roma, Lazio, 00161 Italy
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male adults (aged 18 to 65 years) with Haemophilia A (all severity levels) who
currently use FVIII treatment either prophylactically or on-demand using traditional
factor VIII delivery mechanisms.

- Patients advised for any reason by their physician to switch to a new factor VIII
delivery device, namely FuseNGO, before receiving any details about this study or
Patients who requested to be treated with a new factor VIII delivery device namely
FuseNGO, before receiving any details about this study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients not previously recommended by their physician to switch to this new factor
VIII delivery system or Patients who did not previously ask their physician to be
switched to this new factor VIII delivery system.

- Patients for which it is anticipated that 10 infusions will not occur in the 12
months following their inclusion in the study.

NCT01959919
Pfizer
Completed
Evaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO

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Descriptive Information
Brief TitleEvaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO
Official TitleNon Interventional Longitudinal Study To Assess The Acceptability And The Satisfaction Of Patients With Haemophilia A Treated Both On Demand And On Prophylaxis With A New Factor Viii Delivery System Fusengo
Brief SummaryThis study aims to investigate prospectively throughout a period of 3- 6 months and not to exceed 12 months (according to local therapeutic plans) patients experiences of treatment with Factor VIII in the new device named FuseNGO, a new delivery system for Factor VIII compared to their previous delivery system.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationApproximately 200 patients with Hemophilia A (all severity levels) will be enrolled in approximately 20 centers in Italy.
ConditionHemophilia A
InterventionDevice: Refacto FusENGO
Dosage will be chosen by PI based on patient condition.
Study Groups/CohortsArm 1: Device
Intervention: Device: Refacto FusENGO
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: September 24, 2018)
86
Original Estimated Enrollment
 (submitted: October 9, 2013)
200
Actual Study Completion DateDecember 12, 2016
Actual Primary Completion DateDecember 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male adults (aged 18 to 65 years) with Haemophilia A (all severity levels) who currently use FVIII treatment either prophylactically or on-demand using traditional factor VIII delivery mechanisms.
  • Patients advised for any reason by their physician to switch to a new factor VIII delivery device, namely FuseNGO, before receiving any details about this study or Patients who requested to be treated with a new factor VIII delivery device namely FuseNGO, before receiving any details about this study.

Exclusion Criteria:

  • Patients not previously recommended by their physician to switch to this new factor VIII delivery system or Patients who did not previously ask their physician to be switched to this new factor VIII delivery system.
  • Patients for which it is anticipated that 10 infusions will not occur in the 12 months following their inclusion in the study.
Sex/Gender
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesItaly
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01959919
Other Study ID NumbersB1831081
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2018

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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