Congenital Bleeding DisorderNCT02670213
A Study of Safety and Effectiveness of NovoThirteen® (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan
An observational study of Congenital Bleeding Disorder and Congenital FXIII Deficiency, run by Novo Nordisk A/S at 8 sites in Japan.
Trial summary
This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Bleeding Disorder, Congenital FXIII Deficiency
- What is being tested?
- recombinant factor XIII
- How many people
- 8 participants
- Where
- 8 sitesJapan
- Study dates
- 16 Mar 2016to 30 Sep 2024
- 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: Male or female patients, regardless of age, requiring treatment with NovoThirteenR at the discretion of the treating physician
Who may be able to join
- Male of female patients, regardless of age, requiring treatment with NovoThirteenR for whom the treating physician has decided to use NovoThirteenR (rFXIII) treatment
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Nagoya University Hospital_Blood Transfusion
Aichi, 466-8560
Gamagori Hospital
Gamagori-shi, Aichi, 443-8501
Chugoku Central Hospital
Hiroshima, 720-0001
Kure Medical Center and Chugoku Cancer Center
Kure-shi, Hiroshima, 737-0023
Nikko Memorial Hospital
Muroran, Hokkaido,, 051-8501
Saitama Children's Med Centre_Hematology-Oncology
Saitama, 330-8777
Takashima Municipal Hospital
Shiga, 520-1121
Ogikubo Hospital_Pediatries & Blood
Tokyo, 167-0035
About this study
Official title: A Multicentre, Non-interventional Post Marketing Study of Safety and Effectiveness of NovoThirteenR (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan
This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.
- Being tested
- recombinant factor XIII
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant factor XIIIDrug
No treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| NovoThirteen® | Not described Receives: Drug: recombinant factor XIII |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect
Measured: Year 0-9
Secondary outcomes (7)
All serious adverse events
Measured: Year 0-9
All adverse events
Measured: Year 0-9
All medical event of special interest
Measured: Year 0-9
All medication errors collected
Measured: Year 0-9
All technical complaints
Measured: Year 0-9
Use of NovoThirteen® for other uses than for the approved indication
Measured: Year 0-9
Frequency of bleeding episodes
Measured: Year 0-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start16 Mar 2016
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670213
- Sponsor's protocol ID
- NN1841-4211
- Other IDs
- U1111-1162-5426
- Status last verified
- Aug 2025
- First submitted
- 28 Jan 2016
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. 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 Effectiveness of NovoThirteenR (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan
- ClinicalTrials.gov ID
- NCT02670213
- Acronym / sponsor ID
- NN1841-4211
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Feb 2016 (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. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoThirteen® | – | Drug: recombinant factor XIII |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female patients, regardless of age, requiring treatment with NovoThirteenR at the discretion of the treating physician
Key inclusion criteria (1 listed)
- Male of female patients, regardless of age, requiring treatment with NovoThirteenR for whom the treating physician has decided to use NovoThirteenR (rFXIII) treatment
Key exclusion criteria (0 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 |
|---|---|---|
| recombinant factor XIIINo treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician. | Drug | NovoThirteen® |
Primary outcome
Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect
Time frame: Year 0-9
7 secondary outcomes
All serious adverse events
Time frame: Year 0-9
All adverse events
Time frame: Year 0-9
All medical event of special interest
Time frame: Year 0-9
All medication errors collected
Time frame: Year 0-9
All technical complaints
Time frame: Year 0-9
Use of NovoThirteen® for other uses than for the approved indication
Time frame: Year 0-9
Frequency of bleeding episodes
Time frame: Year 0-9
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 29 Aug 2025.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
8 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 Congenital FXIII Deficiency, run by Novo Nordisk A/S at 8 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 1 inclusion and 0 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 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect (time frame: Year 0-9). 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 29 Aug 2025.