Congenital Bleeding DisorderNCT02207218
To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan
An observational study of Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 2 sites in Japan.
Trial summary
This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A
- What is being tested?
- turoctocog alfa
- How many people
- 40 participants
- Where
- 2 sitesJapan
- Study dates
- 4 Aug 2014to 10 Nov 2020
- Phase
- Observational
- 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
Study population: NovoEight® in prevention, treatment of bleeds and prevention of bleeds during and after surgery in previously treated patients (PTPs) and previously untreated patients (PUPs) with haemophilia A in routine clinical setting in Japan.
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
- Male and female patients with the diagnosis of haemophilia A
- Age range is 0 year and above
- A decision to initiate treatment with commercially available NovoEight® has been made by the patient/parent and the physician
Who cannot join
- Known or suspected allergy to study product(s) or related products
- Previous participation in this study. Participation is defined as informed consent obtained
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, 1670035
Novo Nordisk Investigational Site
Tokyo, 167-0035
About this study
Official title: A Multicentre, Non-interventional Post Marketing Study of Safety and Efficacy of NovoEight® (rFVIII) During Long-Term Treatment of Haemophilia A in Japan
This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Being tested
- turoctocog alfa
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
turoctocog alfaDrug
No treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction of the physician.
| Study group | Role | What they receive |
|---|---|---|
| NovoEight® | Not described Receives: Drug: turoctocog alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (AEs)
Measured: Week 0- 104
Secondary outcomes (10)
Frequency of Adverse Reactions (ARs)
Measured: Week 0- 104
Frequency of Serious Adverse Events (SAEs)
Measured: Week 0- 104
Frequency of Serious Adverse Reactions (SARs)
Measured: Week 0- 104
Haemostatic effect of NovoEight® in the treatment of bleeds according to a predefined four point scale: Excellent, Good, Moderate, or None for patients with preventive regimen and on-demand treatment regimen, respectively
Measured: Week 0- 104
Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None
Measured: Week 0- 104
Annualised bleeding rate for patients using NovoEight® for preventive regimen
Measured: Week 0- 104
Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient)
Measured: Week 0- 104
Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode)
Measured: Week 0- 104
Consumption of NovoEight® per month (IU/kg BW/month) for prevention
Measured: Week 0- 104
Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen
Measured: Week 0- 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study start4 Aug 2014
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry GCR, 1452, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207218
- Sponsor's protocol ID
- NN7008-4105
- Other IDs
- U1111-1144-8212
- Status last verified
- Nov 2021
- First submitted
- 1 Aug 2014
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Non-interventional Post Marketing Study of Safety and Efficacy of NovoEight® (rFVIII) During Long-Term Treatment of Haemophilia A in Japan
- ClinicalTrials.gov ID
- NCT02207218
- Acronym / sponsor ID
- NN7008-4105
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2014 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 4 Aug 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.
This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoEight® | – | Drug: turoctocog alfa |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NovoEight® in prevention, treatment of bleeds and prevention of bleeds during and after surgery in previously treated patients (PTPs) and previously untreated patients (PUPs) with haemophilia A in routine clinical setting in Japan.
Key inclusion criteria (4 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
- Male and female patients with the diagnosis of haemophilia A
- Age range is 0 year and above
- A decision to initiate treatment with commercially available NovoEight® has been made by the patient/parent and the physician
Key exclusion criteria (3 listed)
- Known or suspected allergy to study product(s) or related products
- Previous participation in this study. Participation is defined as informed consent obtained
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
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 |
|---|---|---|
| turoctocog alfaNo treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction of the physician. | Drug | NovoEight® |
Primary outcome
Frequency of Adverse Events (AEs)
Time frame: Week 0- 104
10 secondary outcomes
Frequency of Adverse Reactions (ARs)
Time frame: Week 0- 104
Frequency of Serious Adverse Events (SAEs)
Time frame: Week 0- 104
Frequency of Serious Adverse Reactions (SARs)
Time frame: Week 0- 104
Haemostatic effect of NovoEight® in the treatment of bleeds according to a predefined four point scale: Excellent, Good, Moderate, or None for patients with preventive regimen and on-demand treatment regimen, respectively
Time frame: Week 0- 104
Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None
Time frame: Week 0- 104
Annualised bleeding rate for patients using NovoEight® for preventive regimen
Time frame: Week 0- 104
Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient)
Time frame: Week 0- 104
Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode)
Time frame: Week 0- 104
Consumption of NovoEight® per month (IU/kg BW/month) for prevention
Time frame: Week 0- 104
Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen
Time frame: Week 0- 104
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 Nov 2021.
- Clinical Trials at Novo NordiskLink 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.
Global Clinical Registry GCR, 1452 study director
Novo Nordisk A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 2 sites in Japan.
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 3 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 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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.
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?
Frequency of Adverse Events (AEs) (time frame: Week 0- 104). 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 Nov 2021.