Haemophilia BPhase 3NCT02250560
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.
A Phase 3 study testing Replenine®-VF (High Purity Factor IX) in people with Haemophilia B, run by Bio Products Laboratory at 5 sites in United Kingdom.
Trial summary
The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Haemophilia B
- What is being tested?
- Replenine®-VF (High Purity Factor IX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 5 sitesUnited Kingdom
- Study dates
- Apr 2000to Nov 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with moderate to severe Haemophilia B (≤5% baseline Factor IX level) due to undergo major surgery, previously treated patients, at least 16 years of age without inhibitors, currently receiving Factor IX concentrate.
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road
Basingstoke, RG24 9NA
Haemophilia Centre, The Royal London Hospital, White Chapel
London, E1 1BB
Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street
London, NW3 2QG
Manchester Thrombosis and Haemostasis Centre, University of Manchester, Department of Haematology, Manchester Royal Infirmary, Oxford Road
Manchester, M13 9WL
Haemophilia Centre, Southampton General Hospital, Tremona Road
Southampton, SO16 6YD
About this study
Official title: An Open Study to Investigate the Safety and Efficacy of Replenine®-VF by Continuous Infusion in Haemophilia B Patients Undergoing Major Surgery.
The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery.
- Conditions
- Haemophilia B
- Being tested
- Replenine®-VF (High Purity Factor IX)
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replenine®-VF (High Purity Factor IX)Biological
| Study group | Role | What they receive |
|---|---|---|
| Replenine®-VF | Experimental | Not described Receives: Biological: Replenine®-VF (High Purity Factor IX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of control of prevention of bleeding
Investigator's assessment as excellent, good, moderate or none.
Measured: End of study (Day 5 to Day 10)
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 startApr 2000
- Primary completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia BStudies 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
- NCT02250560
- Sponsor's protocol ID
- R9VFCIMS
- Status last verified
- Aug 2014
- First submitted
- 2 Sep 2014
- Last updated
- 22 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 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 Replenine®-VF by Continuous Infusion in Haemophilia B Patients Undergoing Major Surgery.
- ClinicalTrials.gov ID
- NCT02250560
- Acronym / sponsor ID
- R9VFCIMS
- Conditions
- Haemophilia B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bio Products LaboratoryUniversity, hospital or other
- Study start
- Apr 2000
- Primary completion
- Nov 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 Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Replenine®-VF | Experimental | Biological: Replenine®-VF (High Purity Factor IX) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with moderate to severe Haemophilia B (≤5% baseline Factor IX level) due to undergo major surgery, previously treated patients, at least 16 years of age without inhibitors, currently receiving Factor IX 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 |
|---|---|---|
| Replenine®-VF (High Purity Factor IX) | Biological | Replenine®-VF |
Primary outcome
Assessment of control of prevention of bleeding
Time frame: End of study (Day 5 to Day 10)
Investigator's assessment as excellent, good, moderate or none.
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 22 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 Replenine®-VF (High Purity Factor IX) in people with Haemophilia B, run by Bio Products Laboratory at 5 sites in United Kingdom.
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 22 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 United Kingdom. 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?
Assessment of control of prevention of bleeding (time frame: End of study (Day 5 to Day 10)). 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 22 Feb 2018.