ADVATE Post Authorization Safety Surveillance

Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00214734

Enrollment

108

Registered

2005-09-22

Start date

2004-10-14

Completion date

2007-03-02

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Brief summary

The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.

Interventions

DRUGrAHF-PFM

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%) * Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method) * Subject has been prescribed ADVATE by their treating physician * Subject may be of any age * Subject or parent/legally authorized representative has provided written informed consent

Exclusion criteria

* None

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026