The main purpose of this study is to gather information regarding the safety of ReFacto AF, and how well it works (effectiveness) in very young children with severe Hemophilia A under the age of 6.

Phase 1

• Conditions: Severe hemophilia A (FVIII:C <1%) in male subjects <6 years of age.; MedDRA version: 14.1Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2008-008436-93-NL
• Lead Sponsor: Wyeth Pharmaceutical Inc. Acting through its division Wyeth Research, a Pfizer Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-27
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

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: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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