Von Willebrand DiseasePhase 3NCT02246881
A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.
A Phase 3 study testing Optivate® (Human Coagulation Factor VIII) in people with Von Willebrand Disease, run by Bio Products Laboratory at 8 sites in 2 countries.
Trial summary
The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Von Willebrand Disease
- 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
- Oct 2001to Jan 2004
- 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
- Child, Adult, Older adult
Who may be able to join
- Previously treated subjects with severe Haemophilia A (<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days.
Who cannot join
- -
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United Kingdom5 sites
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, Addenbrooke's Hospital
Hills Road, Cambridge, Cambridgeshire, CB2 2QQ
Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary
Manchester, M13 9WL
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 Lodzi, ul.
Pabianicka 62, 93-513 Lodz
About this study
Official title: An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.
The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.
- Conditions
- Von Willebrand Disease
- Being tested
- Optivate® (Human Coagulation Factor VIII)
- Medical subject headings
- von Willebrand Diseases
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 |
|---|---|---|
| Current Factor VIII | Active comparator | Optivate® (Human Coagulation Factor VIII) Receives: Biological: Optivate® (Human Coagulation Factor VIII) |
| 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.
PK parameters for FVIII:C
Measured: Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startOct 2001
- Primary completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand DiseaseStudies 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
- NCT02246881
- Sponsor's protocol ID
- 8VWFPK
- 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 Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.
- ClinicalTrials.gov ID
- NCT02246881
- Acronym / sponsor ID
- 8VWFPK
- Conditions
- Von Willebrand Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bio Products LaboratoryUniversity, hospital or other
- Study start
- Oct 2001
- Primary completion
- Jan 2004 (actual)
- First posted
- 23 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 compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current Factor VIII | Active comparator | Biological: Optivate® (Human Coagulation Factor VIII)Optivate® (Human Coagulation Factor VIII) |
| Optivate® | Experimental | Biological: Optivate® (Human Coagulation Factor VIII)Optivate® (Human Coagulation Factor VIII) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Previously treated subjects with severe Haemophilia A (<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days.
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 | Current Factor VIII, Optivate® |
Primary outcome
PK parameters for FVIII:C
Time frame: Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose
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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Von Willebrand Diseases
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 Von Willebrand Disease, 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?
PK parameters for FVIII:C (time frame: Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-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.