Haemophilia APhase 3NCT02250482
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
A Phase 3 study testing Optivate® (Human Coagulation Factor VIII) in people with Haemophilia A, run by Bio Products Laboratory at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Haemophilia A
- What is being tested?
- Optivate® (Human Coagulation Factor VIII)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 8 sitesin 2 countries
- Study dates
- Nov 2001to Aug 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United Kingdom5 sites
Haemophilia Centre, Addenbrooke's Hospital, Hills Road
Cambridge, CB2 2QQ
Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary
Manchester, M13 9WL
Haemophilia Centre, University Hospital, Queens Medical Centre, Clifton Boulevard
Nottingham, N67 2UH
Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road
Sheffield, S10 2JF
Haemophilia Centre, Southampton General Hospital, Tremona Road
Southampton, SO16 6YD
Poland3 sites
Klinika Haematologii, Akademia Medyczna w Gdansku, ul.
Debinki 7, 80-211 Gdansk
Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
Dr K Jaczewskiego 8, 20-090, Lublin
Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.
Szkolna 8/12, 61-833 Poznan
About this study
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.
- Conditions
- Haemophilia A
- Being tested
- Optivate® (Human Coagulation Factor VIII)
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optivate® (Human Coagulation Factor VIII)Biological
| Study group | Role | What they receive |
|---|---|---|
| Optivate® | Experimental | Optivate® (Human Coagulation Factor VIII) Receives: Biological: Optivate® (Human Coagulation Factor VIII) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Recovery for plasma Factor VIII
Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG
Measured: 90 minutes after pre-operative bolus dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startNov 2001
- Primary completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Bio Products Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250482
- Sponsor's protocol ID
- 8VWF02
- Status last verified
- Feb 2018
- First submitted
- 2 Sep 2014
- Last updated
- 15 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
- ClinicalTrials.gov ID
- NCT02250482
- Acronym / sponsor ID
- 8VWF02
- Conditions
- Haemophilia A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bio Products LaboratoryUniversity, hospital or other
- Study start
- Nov 2001
- Primary completion
- Aug 2003 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optivate® | Experimental | Biological: Optivate® (Human Coagulation Factor VIII)Optivate® (Human Coagulation Factor VIII) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optivate® (Human Coagulation Factor VIII) | Biological | Optivate® |
Primary outcome
Incremental Recovery for plasma Factor VIII
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Optivate® (Human Coagulation Factor VIII) in people with Haemophilia A, run by Bio Products Laboratory at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Recovery for plasma Factor VIII (time frame: 90 minutes after pre-operative bolus dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.