HemophiliaSERAPHINENCT04808349
Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery
An observational study of Hemophilia, run by Nantes University Hospital at 3 sites in France.
Trial summary
the aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophilia
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Jul 2021to 30 Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In order to respect the independence of the physicians, this study is conducted with patients for whom the decision to prescribe turoctocog alfa (NovoEight®) treatment is not related to the study. The prescription of turoctocog alfa (NovoEight®) will therefore have been carried out on the initiative of the physicians of the participating centers, in collaboration with the patients involved. This study therefore does not lead to any change in the usual medical care of the people entering the study, nor does it affect the physical or psychological integrity of the patients.
Who may be able to join
- Male or female
- Regardless of age
- No inhibitor (anti-FVIII alloantibodies) at the time of treatment.
- No objections expressed to participate in the study after having been informed of its purposes and the data involved.
- No other inherited hemorrhagic disorders than HA
Who cannot join
- In order to reflect the reality of daily practice, no criteria for non-inclusion are provided for other than the refusal of the patient or his or her legal representative to participate in the study or the existence in the patient of a contraindication to the use of turoctocog alfa (NovoEight®) treatment.
Trial locations and contacts
3 sites in 1 country.
About this study
the aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Database for Research on Hemostasis for the Investigators of Western France), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (NovoEight®) in surgery in pwHA (Patient with inherited Hemophilia A).
- Conditions
- Hemophilia
- Being tested
- no intervention
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA
Overall evaluation by the investigator of the hemostatic effectiveness of turoctocog alfa (NovoEight®) for the prevention of hemorrhagic complications in a surgical setting (excellent, good, fair, poor/none according to recommendations of the SSC of ISTH)
Measured: 1 year
Secondary outcomes (2)
Assessing the safety of turoctocog alfa (NovoEight®) when used during surgery in patients with the occurrence of adverse events (AEs), especially hemorrhagic and thrombotic complications or development of inhibitors.
Nature and incidence of AEs, including serious AEs, AEs related to turoctocog alfa (NovoEight®)
Measured: 1 year
Assessing the duration of replacement therapy and factor VIII consumption in clinical practice during surgery in patients treated with turoctocog alfa (NovoEight®)
Number of administrations and total required dose of turoctocog alfa (NovoEight®) in IU/kg
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start2 Jul 2021
- Primary completion31 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808349
- Sponsor's protocol ID
- RC21_0053
- Acronym
- SERAPHINE
- Status last verified
- Nov 2022
- First submitted
- 16 Mar 2021
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery
- ClinicalTrials.gov ID
- NCT04808349
- Acronym / sponsor ID
- SERAPHINE / RC21_0053
- Conditions
- Hemophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- 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 aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Database for Research on Hemostasis for the Investigators of Western France), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (NovoEight®) in surgery in pwHA (Patient with inherited Hemophilia A).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In order to respect the independence of the physicians, this study is conducted with patients for whom the decision to prescribe turoctocog alfa (NovoEight®) treatment is not related to the study. The prescription of turoctocog alfa (NovoEight®) will therefore have been carried out on the initiative of the physicians of the participating centers, in collaboration with the patients involved. This study therefore does not lead to any change in the usual medical care of the people entering the study, nor does it affect the physical or psychological integrity of the patients.
Key inclusion criteria (5 listed)
- Male or female
- Regardless of age
- No inhibitor (anti-FVIII alloantibodies) at the time of treatment.
- No objections expressed to participate in the study after having been informed of its purposes and the data involved.
- No other inherited hemorrhagic disorders than HA
Key exclusion criteria (1 listed)
- In order to reflect the reality of daily practice, no criteria for non-inclusion are provided for other than the refusal of the patient or his or her legal representative to participate in the study or the existence in the patient of a contraindication to the use of turoctocog alfa (NovoEight®) treatment.
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA
Time frame: 1 year
Overall evaluation by the investigator of the hemostatic effectiveness of turoctocog alfa (NovoEight®) for the prevention of hemorrhagic complications in a surgical setting (excellent, good, fair, poor/none according to recommendations of the SSC of ISTH)
2 secondary outcomes
Assessing the safety of turoctocog alfa (NovoEight®) when used during surgery in patients with the occurrence of adverse events (AEs), especially hemorrhagic and thrombotic complications or development of inhibitors.
Time frame: 1 year
Assessing the duration of replacement therapy and factor VIII consumption in clinical practice during surgery in patients treated with turoctocog alfa (NovoEight®)
Time frame: 1 year
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 25 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia, run by Nantes University Hospital at 3 sites in France.
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 5 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 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA (time frame: 1 year). 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 25 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.