Haemophilia BPhase 3NCT02263456

A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B

A Phase 3 study testing Replenine®-VF (High Purity Factor IX) in people with Haemophilia B, run by Bio Products Laboratory at 7 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is: to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg. Read more about this study

Who is it for?: Ages 12 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: 7 sitesUnited Kingdom
Study dates: Jul 1997to Sep 2001
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

Patients aged 12 years or over
At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product

Who cannot join

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United Kingdom7 sites

The North Hampshire Hospital, Aldermaston Road
Basingstoke
Addenbrooke's Hospital, Hills Road
Cambridge
University Hospital of Wales, Health Park
Cardiff
The Royal Free Hospital, Pond Street
Hampstead, London
Kingston General Hospital, Beverly Road
Hull
Leicester Royal Infirmary, Infirmary Square
Leicester
Lincoln County Hospital, Greetwell Road
Lincoln

Other trials in United Kingdom

About this study

Official title: An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, in Severe Haemophilia B Patients.

The purpose of this study is:

to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg.
to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches.
to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.

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 groups in NCT02263456
Study group	Role	What they receive
Current Factor IX	Active comparator	Not described Receives: Biological: Replenine®-VF (High Purity Factor IX)
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.

Area under the concentration/time curve (AUC) for plasma Factor IX
Measured: Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 1997Sep 2001

First posted13 Oct 2014 (estimated)
Study startJul 1997
Primary completionSep 2001

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT02263456
Sponsor's protocol ID: RP9VFPK
Status last verified: Aug 2014
First submitted: 2 Sep 2014
Last updated: 13 Oct 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
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A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
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Safety of Intraosseous Anaesthesia in Children With Haemophilia
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Lentiviral FIX Gene Therapy
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A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia

All Haemophilia B trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2014. 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 Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, in Severe Haemophilia B Patients.
ClinicalTrials.gov ID: NCT02263456
Acronym / sponsor ID: RP9VFPK
Conditions: Haemophilia B
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Bio Products LaboratoryUniversity, hospital or other
Study start: Jul 1997
Primary completion: Sep 2001 (actual)
First posted: 13 Oct 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 purpose of this study is:

to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg.
to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches.
to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.

Study design

Primary purpose: Treatment
Number of arms: 2

Arm	Type	Receives
Current Factor IX	Active comparator	Biological: Replenine®-VF (High Purity Factor IX)
Replenine®-VF	Experimental	Biological: Replenine®-VF (High Purity Factor IX)

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Patients aged 12 years or over
At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product

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	Current Factor IX, Replenine®-VF

Primary outcome

Area under the concentration/time curve (AUC) for plasma Factor IX
Time frame: Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr 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 13 Oct 2014.
Related InfoLink provided by the sponsor.

Related trials for Haemophilia B

Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruitingPhase 1
Lentiviral FIX Gene Therapy
Hemophilia B
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia

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.

7 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 7 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 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 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Area under the concentration/time curve (AUC) for plasma Factor IX (time frame: Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02263456.

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 13 Oct 2014.