Hemophilia BPhase 4NCT00139828
Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
A Phase 4 study testing human coagulation Factor IX in people with Hemophilia B, run by Prothya Biosolutions at 7 sites in Netherlands.
Trial summary
In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is evaluated in previous treated and untreated patients with severe, moderate or mild haemophilia B. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Hemophilia B
- What is being tested?
- human coagulation Factor IX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 7 sitesNetherlands
- Study dates
- May 2003to Feb 2007
- Phase
- Phase 4
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers of Haemophilia B and Haemophilia B Leyden
- Above the age of six, at the moment of inclusion
- Tested positive for HAV and HBV antibodies, induced by infection or vaccination, and negative for HBsAg
- Informed consent signed by the patients or his legally accepted representative
Who cannot join
- Under the age of six, at the moment of inclusion
- Tested negative for HAV and HBV antibodies
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Academic Medical Centre
Amsterdam, 1105 AZ
Kennemer Gasthuis
Haarlem
LUMC
Leiden, 2333 ZA
UMC St. Radboud
Nijmegen, 6525 GA
Erasmus Medical Centre
Rotterdam, 3015 GD
Leyenburg Hospital
The Hague, 2545 CH
Van Creveldkliniek
Utrecht, 3584CX
About this study
Official title: Post Marketing Study in Haemophilia B Patients Using Nonafact® 100 IU/ml Powder and Solvent for Solution for Injection(Human Coagulation Factor IX)(Human Plasma Derived Factor IX Product, Freeze Dried)
In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is evaluated in previous treated and untreated patients with severe, moderate or mild haemophilia B.
Read the detailed description
The clinical efficacy and safety of Nonafact® has been shown in two pre-authorisation studies. Marketing authorisation for the EU was granted 3 July 2001. The Post Marketing Study, which evaluates the clinical efficacy, immunogenicity and safety of Nonafact®, is set up according to CPMP/BPWG /198/95, rev. 1 (Final, London, 19 October 2000) 'Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products'
- Conditions
- Hemophilia B
- Being tested
- human coagulation Factor IX
- Keywords
- haemophilia B, factor IX, Product Surveillance, Postmarketing, plasma products
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human coagulation Factor IXDrug
Also called Nonafact
| Study group | Role | What they receive |
|---|---|---|
| A | Other | The amount of Nonafact® to be administered and the frequency of treatment is based on the SmPC and should always be determined on the basis of the clinical effectiveness in the individual patient Receives: Drug: human coagulation Factor IX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding episodes (efficacy after administration)
Measured: 24 months
Haematological variables and clinical chemistry (safety)
Measured: 24 months
Adverse events (safety)
Measured: 24 months
Secondary outcomes (1)
Occurrence of antibodies to factor IX
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startMay 2003
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prothya Biosolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- E P Mauser-Bunschoten, MD, PdD, Principal investigator, UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139828
- Sponsor's protocol ID
- KB2000.03
- Status last verified
- Aug 2007
- First submitted
- 30 Aug 2005
- Last updated
- 30 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Study in Haemophilia B Patients Using Nonafact® 100 IU/ml Powder and Solvent for Solution for Injection(Human Coagulation Factor IX)(Human Plasma Derived Factor IX Product, Freeze Dried)
- ClinicalTrials.gov ID
- NCT00139828
- Acronym / sponsor ID
- KB2000.03
- Conditions
- Hemophilia B
- Keywords
- haemophilia B, factor IX, Product Surveillance, Postmarketing, plasma products
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Prothya BiosolutionsIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Feb 2007 (actual)
- First posted
- 31 Aug 2005 (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.
In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is evaluated in previous treated and untreated patients with severe, moderate or mild haemophilia B.
Detailed description
The clinical efficacy and safety of Nonafact® has been shown in two pre-authorisation studies. Marketing authorisation for the EU was granted 3 July 2001. The Post Marketing Study, which evaluates the clinical efficacy, immunogenicity and safety of Nonafact®, is set up according to CPMP/BPWG /198/95, rev. 1 (Final, London, 19 October 2000) 'Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products'
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: human coagulation Factor IXThe amount of Nonafact® to be administered and the frequency of treatment is based on the SmPC and should always be determined on the basis of the clinical effectiveness in the individual patient |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers of Haemophilia B and Haemophilia B Leyden
- Above the age of six, at the moment of inclusion
- Tested positive for HAV and HBV antibodies, induced by infection or vaccination, and negative for HBsAg
- Informed consent signed by the patients or his legally accepted representative
Key exclusion criteria (2 listed)
- Under the age of six, at the moment of inclusion
- Tested negative for HAV and HBV antibodies
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 |
|---|---|---|
| human coagulation Factor IXAlso: Nonafact | Drug | A |
Primary outcome
Number of bleeding episodes (efficacy after administration)
Time frame: 24 months
Haematological variables and clinical chemistry (safety)
Time frame: 24 months
Adverse events (safety)
Time frame: 24 months
1 secondary outcome
Occurrence of antibodies to factor IX
Time frame: 24 months
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 30 Aug 2007.
Related trials for Hemophilia B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
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
RecruitingPhase 3
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
Hemophilia A
Not yet recruitingPhase 1
Lentiviral FIX Gene Therapy
Hemophilia B
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.
E P Mauser-Bunschoten, MD, PdD principal investigator
UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing human coagulation Factor IX in people with Hemophilia B, run by Prothya Biosolutions at 7 sites in Netherlands.
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 4 inclusion and 2 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 30 Aug 2007. 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of bleeding episodes (efficacy after administration) (time frame: 24 months). The study lists 3 primary outcomes in all. 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 30 Aug 2007; AzTrials last refreshed its copy on 6 Nov 2026.