Clinical trial NCT01959919: Evaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO
Official title: Non 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 86
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 200 patients with Hemophilia A (all severity levels) will be enrolled in approximately 20 centers in Italy.

Brief summary: This 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.


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.

Primary outcomes:
measure: Ease of Using Clotting Factor Treatment Score
timeFrame: Final Visit (Month 8)
measure: Time for Reconstructing the Drug
timeFrame: Final Visit (Month 8)
measure: Burden of Clotting Factor Treatment Score
timeFrame: Final Visit (Month 8)
measure: Impact of Clotting Factor Treatment Score
timeFrame: Final Visit (Month 8)
measure: Risk Associated With Clotting Factor Treatment Score
timeFrame: Final Visit (Month 8)
measure: Overall Satisfaction Score With Refacto AF FuseNGO
timeFrame: Final Visit (Month 8)
Secondary outcomes:
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Baseline up to 28 days after last dose of drug (up to Month 12)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Istituto di Ematologia
state: Lazio
city: Sassari
country: Italy
facility: Ospedale SS. Annunziata - USL 1
state: Sardegna
city: Bari
country: Italy
facility: Azienda Ospedale Policlinico Consorziale
city: Cagliari
country: Italy
facility: Struttura Complessa Di Oncoematologia Pediatrica E Patologia Della Coagulzione
city: Catania
country: Italy
facility: Ospedale Ferrarrotto
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Ciaccio - Ospedale Pugliese
city: Firenze
country: Italy
facility: Azienda Ospedaliera Careggi
city: Macerata
country: Italy
facility: Centro regionale di diagnosi e trattamento dell'Emofilia e delle malattie dell'emostasi e trombosi
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico Mangiagalli E Regina Elena
city: Napoli
country: Italy
facility: Dipartimento Medicina Clinica e Sperimentale
city: Napoli
country: Italy
facility: Centro Emofilia e Trombosi - Centro delle Microcitemie
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Policlinico P Giaccone
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova, AO di Reggio Emilia
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli
city: Torino
country: Italy
facility: Ospedale Molinette
city: Torino
country: Italy
facility: SC Servizio Immunotrasfusionale
city: Udine
country: Italy
facility: SOS Malattie Emorragiche e Trombotiche AOU "S.M.M." Udine
city: Verona
country: Italy
facility: Anna Chiara Giuffrida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: