An Open-Label Study of the Safety and Efficacy of ReFacto AF in Previously Untreated Patients in Usual Care SettingsEstudio abierto sobre seguridad y eficacia de ReFacto AF en pacientes no tratados previamente, en condiciones asistenciales habituales

Phase 1

• Conditions: Severe hemophilia A (FVIII:C <1%) in male subjects <6 years of age.Hemofilia A severa (FVIII:C<1%) en sujetos pediátricos menores de seis años de edad.; MedDRA version: 9.1Level: LLTClassification code 10018937Term: Haemophilia A

• Registration Number: EUCTR2008-008436-93-ES
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-29
• Study Completion: 2016-11-24
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 23

Inclusion Criteria

1) Male subjects <6 years of age with severe hemophilia A (FVIII:C <1%) based on clinical records, including newborns.

2) No prior exposure to factor products or any blood products.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Presence of any bleeding disorder in addition to hemophilia A.

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

3) 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified