Haemophilia BPhase 3NCT02250573
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing 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 3 countries.
Trial summary
The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery. Read more about this study
- Who is it for?
- Any age
- 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 sitesin 3 countries
- Study dates
- Dec 2005to Apr 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days.
Who cannot join
- -
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Romania2 sites
Institutul National de Haemtologie, 2-8 Constantin Caracas Str.
Bucharest
Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2.
Timișoara
Russia2 sites
Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul.
Kirov, 610027
Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed.
Moscow, 125167
Poland1 site
Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8.
Poznan, 61-825
About this study
Official title: An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery.
The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing 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.
Incremental recovery for Factor IX
Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG
Measured: 90 min post-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 startDec 2005
- Primary completionApr 2006
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
- 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
- NCT02250573
- Sponsor's protocol ID
- R9VFSUR
- Status last verified
- Feb 2018
- 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 in Haemophilia B Subjects Undergoing Surgery.
- ClinicalTrials.gov ID
- NCT02250573
- Acronym / sponsor ID
- R9VFSUR
- Conditions
- Haemophilia B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bio Products LaboratoryUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Apr 2006 (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 objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Replenine®-VF | Experimental | Biological: Replenine®-VF (High Purity Factor IX) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 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 |
|---|---|---|
| Replenine®-VF (High Purity Factor IX) | Biological | Replenine®-VF |
Primary outcome
Incremental recovery for Factor IX
Time frame: 90 min post-dose
Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX 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 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 3 countries: 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 3 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 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 Romania, Russia, 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 Factor IX (time frame: 90 min 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 22 Feb 2018.