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Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting

Information source: Pfizer
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A

Intervention: Laboratory Tests (Procedure)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia. Study subjects will be males less than 6 years old who have not taken any clotting factor or other blood products before the study. The safety and effectiveness of ReFacto AF will be determined in this study by tests and procedures done at the doctor's office.

Clinical Details

Official title: An Open-label Study Of The Safety And Efficacy Of Refacto Af In Previously Untreated Patients In Usual Care Settings.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Proportion of subjects who develop clinically significant FVIII inhibitors during the course of the study.

Secondary outcome:

Annualized bleeding rates.

Responses to the first on-demand treatment with Refacto AF for all new bleeds.

The number of ReFacto AF infusions to treat each new bleed.

The number of bleeds within 48 hours of a prophylaxis dose of ReFacto AF.

The average infusion dose and total factor consumption

The number of subjects who require dose escalation of their prescribed prophylaxis regimen during their participation in this study.

The incidence of less-than-expected therapeutic effect (LETE).

Detailed description: Regulatory Commitment

Eligibility

Minimum age: N/A. Maximum age: 6 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male subjects <6 years of age with severe hemophilia A (FVIII: C <1%) based on

clinical records, including newborns.

- No prior exposure to factor products or any blood products.

Exclusion Criteria:

- Presence of any bleeding disorder in addition to hemophilia A.

- Treatment with any investigational agent or device within the past 30 days.

- Any condition(s) that compromises the ability to collect study-related observations,

or that poses a contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; and expectation of poor adherence to study requirements).

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

CHU de Nantes, Nantes 44093, France; Active, not recruiting

LTD Medinvesti- Institute of Hematology and Transfuziology, Tbilisi, Georgia; Not yet recruiting

Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik, Bremen 28177, Germany; Active, not recruiting

Medizinische Hochschule, Hannover, Hannover 30625, Germany; Recruiting

Olgahospital, Stuttgart 70176, Germany; Recruiting

Haemophilia Center/Haemostasis Unit, Athens 11527, Greece; Recruiting

A' University Department of Paediatrics, Thessaloniki 546 42, Greece; Recruiting

Azienda Ospedaliera Careggi, Firenze 50134, Italy; Active, not recruiting

Universitair Medisch Centrum Groningen, Groningen 9713 GZ, Netherlands; Recruiting

Complexo Hospitalario Juan Canalejo, A Coruna 15006, Spain; Recruiting

Complejo Hospitalario Torrecardenas, Almeria 04009, Spain; Recruiting

Hospital La Paz, Madrid 28046, Spain; Recruiting

Hospital Universitario Central de Asturias, Oviedo 33006, Spain; Recruiting

Hospital Universitario Virgen del Rocio, Sevilla 41013, Spain; Recruiting

Hospital Polit├ęcnico Universitario La Fe, Valencia 46026, Spain; Recruiting

Hospital Universitario y Polit├ęcnico La Fe, Valencia 46026, Spain; Recruiting

Akdeniz Universitesi Tip Fakultesi, Antalya 07059, Turkey; Recruiting

Cukurova Universitesi Tip Fakultesi, Balcali/Adana 01330, Turkey; Recruiting

Ege Universitesi Tip Fakultesi, Bornova/Izmir 35100, Turkey; Recruiting

Istanbul Universitesi Cerrahpasa Tip Fakultesi, Fatih/Istanbul 34098, Turkey; Recruiting

State institution "The Institute of blood pathology and transfusion medicine of AMS of Ukraine", Lviv 79044, Ukraine; Recruiting

Oblasna Klinichna Dytiacha Likarnia, Hematolohichne Viddilennia, Zaporizhzhia 69063, Ukraine; Not yet recruiting

Klinikum Stuttgart-Olgahospital, Stuttgart, Baden-Wuerttemberg 70176, Germany; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: February 2010
Last updated: November 4, 2014

Page last updated: November 27, 2014

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