An Open-Label Study of the Safety and Efficacy of ReFacto AF in Previously Untreated Patients in Usual Care Settings

Phase 4

Completed

• Conditions: 10064477; factor VIII deficiency; Hemophilia A; 10005330

• Registration Number: NL-OMON39506
• Lead Sponsor: Pfizer

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-11-02
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1

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.

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
• Study Design: Not specified