An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02250482

Enrollment

Unknown

Registered

2014-09-26

Start date

2001-11-30

Completion date

Unknown

Last updated

2018-02-15

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

Conditions

Haemophilia A

Brief summary

The main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.

Interventions

BIOLOGICALOptivate® (Human Coagulation Factor VIII)

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Incremental Recovery for plasma Factor VIII	90 minutes after pre-operative bolus dose	Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG

Countries

Poland, United Kingdom

Outcome results

None listed

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