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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02246868

Enrollment

Unknown

Registered

2014-09-23

Start date

2001-09-30

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 objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.

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

* Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Incremental Recovery	Comparison of Baseline with 3 months post-baseline

Countries

Poland, United Kingdom

Outcome results

None listed

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