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

NCT02246868 | Completed Phase 3

• 1 other identifier: 8VWFSE
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 11

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®.

Conditions

Haemophilia A

Outcome Measures

Primary Outcomes (1)

• Incremental Recovery

  Comparison of Baseline with 3 months post-baseline

Study Arms (1)

Optivate®

EXPERIMENTAL

Optivate® (Human Coagulation Factor VIII)

Biological: Optivate® (Human Coagulation Factor VIII)

Interventions

Optivate® (Human Coagulation Factor VIII) BIOLOGICAL

Optivate®

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Bio Products Laboratory: lead

Study Sites (11)

Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.

Bialystok, Poland

Location

Klinika Haematologii, Akademia Medyczna w Gdansku, u.

Gdansk, Poland

Location

Klinika Haematologii, Akademia Medyczna w Lodzi, ul.

Lodz, Poland

Location

Klinika Haematologii, Akademia Medyczna w Lublinie, ul.

Lublin, Poland

Location

Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.

Poznan, Poland

Location

Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul.

Wroclaw, Poland

Location

Haemophilia Centre, Addenbrooke's Hospital, Hills Road

Cambridge, CB2 2QQ, United Kingdom

Location

Haemophilia Centre, University Department of Haemophilia Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Haemophilia Centre, University Hospital, Queen's Medical Centre, Clifton Boulevard

Nottingham, NG7 2UH, United Kingdom

Location

Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road

Sheffield, S10 2JF, United Kingdom

Location

Haemophilia Centre, Southampton General Hospital, Tremona Road

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hemophilia A

Interventions

optivate; Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 23, 2014
• Study Start: September 1, 2001
• Primary Completion: August 1, 2004
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

PL (6); GB (5)