N/A Completed N=101

Study Evaluating Pharmacovigilance Of Refacto AF

Hemophilia A

Source: ClinicalTrials.gov NCT00895037 ↗

Enrolled (actual)

101

Serious AEs

33.7%

Results posted

Jul 2018

Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 15; 59; 2; 7 participants

Summary

The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	15; 59; 2; 7; 25; 2	—
PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)	2; 7; 0; 0; 0; 0	—
PRIMARY Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay	1; 2; 0	—
PRIMARY Mean Total Number of Bleeding Episodes in Participants	71.2; 15.4; 68.5	—
SECONDARY Mean Total Number of Bleeding Episodes Per Year in Participants	18.6; 5.1; 13.4	—
SECONDARY Number of Participants With Change From Baseline Status in Days Missed From School or Work	4; 25; 4; 29; 3; 6	—
SECONDARY Participant Assessment of Satisfaction With Treatment Handling	13; 42; 0; 5; 28; 2	—
SECONDARY Investigator Assessment of Treatment Satisfaction of Participants	13; 44; 0; 4; 29; 2	—

Eligibility Criteria

Inclusion Criteria

Patients with hemophilia A of any severity already receiving or starting treatment with ReFacto AF.

Exclusion Criteria

Patients with Hemophilia A treated with a product other than Refacto AF.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00895037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.