NL-OMON39506
Completed
Phase 4
An Open-Label Study of the Safety and Efficacy of ReFacto AF in Previously Untreated Patients in Usual Care Settings - B1831006
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- factor VIII deficiency
- Sponsor
- Pfizer
- Enrollment
- 1
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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