Haemophilia APhase 3NCT02246894
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
A Phase 3 study testing Optivate® (Human Coagulation Factor VIII) in people with Haemophilia A, run by Bio Products Laboratory at 5 sites in Poland.
Trial summary
The main objectives of this study are: to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed). to assess clinical outcome when treating a bleed with Optivate®. Read more about this study
- Who is it for?
- Ages Up to 6 years
- 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
- 5 sitesPoland
- Study dates
- Nov 2003to Jan 2005
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.
- Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.
Krakow, 30-663
Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.
Poznan, 61-825
Children's Haematology and Oncology Clinic, Ul.
W. Chodzki Str., Lublin Voivodeship, 20-093
Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.
Warsaw, 00-576
Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str.
Wroclaw, 50-345
About this study
Official title: An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.
The main objectives of this study are:
- to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
- to assess clinical outcome when treating a bleed with Optivate®.
- to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
- to assess FVIII inhibitor development during the study.
- 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.
Consumption of FVIII
Measured: Day 0 to Week 26
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 startNov 2003
- Primary completionJan 2005
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
Sponsor and investigators
- Lead sponsor
- Bio Products Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246894
- Sponsor's protocol ID
- 8VWF05
- 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 Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.
- ClinicalTrials.gov ID
- NCT02246894
- Acronym / sponsor ID
- 8VWF05
- Conditions
- Haemophilia A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bio Products LaboratoryUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Jan 2005 (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 objectives of this study are:
- to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
- to assess clinical outcome when treating a bleed with Optivate®.
- to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
- to assess FVIII inhibitor development during the study.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optivate® | Experimental | Biological: Optivate® (Human Coagulation Factor VIII)Optivate® (Human Coagulation Factor VIII) |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.
- Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.
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
Consumption of FVIII
Time frame: Day 0 to Week 26
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.
5 sites in 1 country: 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 5 sites in Poland.
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 2 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 5 sites in 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?
Consumption of FVIII (time frame: Day 0 to Week 26). 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.