Hemophilia ACHALENCT06158334
Study of Surgical Practices in Patients With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)
An observational study of Hemophilia A and Hemophilia B, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Haemophilia A and haemophilia B are inherited bleeding disorders resulting from the absence or deficiency of coagulation factors VIII and IX, respectively. The peri-operative period of people with haemophilia is commonly managed with replacement therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A, Hemophilia B
- What is being tested?
- Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical procedures and Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical procedures
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 1 Dec 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: Patients (minor and adults) with Haemophilia A or B for whom minor and major surgeries is performed with Elocta® or Alprolix®.
Who may be able to join
- patient with Haemophilia A or B
- surgery performed with Elocta® or Alprolix®
- Information leaflet given to the patient who as reached the age of majority or to the parents or legal guardian for minors
Who cannot join
- Any blood coagulation disorder other than Haemophilia A or B
- Patient with factor VIII or IX inhibitor
- Severe liver disease (serum ALAT/ASAT levels> 5 x ULN)
- Severe renal disease (serum creatinine > 2x ULN)
- Known hypersensitivity to the substances or its excipients
- patient participating in another clinical trial or having participated in another clinical trial within the previous 30 days (non-interventional studies are not a criterion for non-inclusion)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Référence en Hémophilie, hôpityal Louis Pradel, GHE- Hospices Civils de Lyon
Bron
Anne LIENHART, MD
About this study
Official title: Study of Surgical Practices in Patient With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)
Haemophilia A and haemophilia B are inherited bleeding disorders resulting from the absence or deficiency of coagulation factors VIII and IX, respectively. The peri-operative period of people with haemophilia is commonly managed with replacement therapy.
In phase 3 studies of Elocta® (extended half-life recombinant factor VIII-Fc) and Alprolix® (extended half-life recombinant factor IX-Fc), haemostatic efficacy was demonstrated to be good or excellent, close to the haemostatic efficacy usually seen in people without haemophilia, with maintenance and stability of circulating FVIII and FIX levels compatible with the surgical procedure, while reducing the frequency of infusions and consumption of therapeutic units. In 2019, the National Protocol for Diagnosis and Care in haemophilia recommended 2 methods for managing patients with haemophilia in the peri-operative period, either discontinuous injections of standard or extended half-life factor VIII/IX or a continuous infusion of FVIII/IX.
Many countries, including France, have adopted these rFVIII/IXFc therapeuitic products and recommended their use in the surgical management of patients. However, the use of these two products in real life during surgery in haemophilic A and B patients has not been described in detail. It seems therefore relevant to better document their use in order to progressively specify their use during surgeries with varied bleeding risks.
- Conditions
- Hemophilia A, Hemophilia B
- Being tested
- Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical procedures, Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical procedures
- Keywords
- surgery, Haemophilia A, Haemophilia B, Elocta®, Alprolix®
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical proceduresDrug
All surgical data will be collected: surgery, biology, administration of Elocta®, bleeding and transfusion, hemostatic efficacity, surgery complication and bleeding
Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical proceduresDrug
All surgical data will be collected: surgery, biology, administration of Alprolix®, bleeding and transfusion, hemostatic efficacity, surgery complication and bleeding…
| Study group | Role | What they receive |
|---|---|---|
| Minor and major surgeries of patients with haemophilia A treated with Elocta® | Description of all surgical data (minor and major) on Elocta® (all dosage and treatment regimens) Receives: Drug: Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical procedures | |
| Minor and major surgeries of patients with haemophilia B treated with Alprolix® | Description of all surgical data (minor and major) on Alprolix® (all dosage and treatment regimens) Receives: Drug: Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative haemostatic efficacy described in real life with ELOCTA® and ALPROLIX® in haemophilia A and B patients. Haemostatic efficacy is defined by excellent, good, fair, poor.
changes in hemostatic efficacy between surgery and 15 days post-surgery
Measured: 15 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158334
- Sponsor's protocol ID
- 868
- Acronym
- CHALE
- Status last verified
- Nov 2023
- First submitted
- 19 Jun 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Surgical Practices in Patient With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)
- ClinicalTrials.gov ID
- NCT06158334
- Acronym / sponsor ID
- CHALE / 868
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- surgery, Haemophilia A, Haemophilia B, Elocta®, Alprolix®
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Dec 2023 (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.
Haemophilia A and haemophilia B are inherited bleeding disorders resulting from the absence or deficiency of coagulation factors VIII and IX, respectively. The peri-operative period of people with haemophilia is commonly managed with replacement therapy.
In phase 3 studies of Elocta® (extended half-life recombinant factor VIII-Fc) and Alprolix® (extended half-life recombinant factor IX-Fc), haemostatic efficacy was demonstrated to be good or excellent, close to the haemostatic efficacy usually seen in people without haemophilia, with maintenance and stability of circulating FVIII and FIX levels compatible with the surgical procedure, while reducing the frequency of infusions and consumption of therapeutic units. In 2019, the National Protocol for Diagnosis and Care in haemophilia recommended 2 methods for managing patients with haemophilia in the peri-operative period, either discontinuous injections of standard or extended half-life factor VIII/IX or a continuous infusion of FVIII/IX.
Many countries, including France, have adopted these rFVIII/IXFc therapeuitic products and recommended their use in the surgical management of patients. However, the use of these two products in real life during surgery in haemophilic A and B patients has not been described in detail. It seems therefore relevant to better document their use in order to progressively specify their use during surgeries with varied bleeding risks.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minor and major surgeries of patients with haemophilia A treated with Elocta® | – | Drug: Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical proceduresDescription of all surgical data (minor and major) on Elocta® (all dosage and treatment regimens) |
| Minor and major surgeries of patients with haemophilia B treated with Alprolix® | – | Drug: Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical proceduresDescription of all surgical data (minor and major) on Alprolix® (all dosage and treatment regimens) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (minor and adults) with Haemophilia A or B for whom minor and major surgeries is performed with Elocta® or Alprolix®.
Key inclusion criteria (3 listed)
- patient with Haemophilia A or B
- surgery performed with Elocta® or Alprolix®
- Information leaflet given to the patient who as reached the age of majority or to the parents or legal guardian for minors
Key exclusion criteria (6 listed)
- Any blood coagulation disorder other than Haemophilia A or B
- Patient with factor VIII or IX inhibitor
- Severe liver disease (serum ALAT/ASAT levels> 5 x ULN)
- Severe renal disease (serum creatinine > 2x ULN)
- Known hypersensitivity to the substances or its excipients
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 |
|---|---|---|
| Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical proceduresAll surgical data will be collected: surgery, biology, administration of Elocta®, bleeding and transfusion, hemostatic efficacity, surgery complication and bleeding | Drug | Minor and major surgeries of patients with haemophilia A treated with Elocta® |
| Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical proceduresAll surgical data will be collected: surgery, biology, administration of Alprolix®, bleeding and transfusion, hemostatic efficacity, surgery complication and bleeding… | Drug | Minor and major surgeries of patients with haemophilia B treated with Alprolix® |
Primary outcome
Perioperative haemostatic efficacy described in real life with ELOCTA® and ALPROLIX® in haemophilia A and B patients. Haemostatic efficacy is defined by excellent, good, fair, poor.
Time frame: 15 days post-surgery
changes in hemostatic efficacy between surgery and 15 days post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and Hemophilia B, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne LIEHNART, MD (+33 4 72 11 88 10, anne.lienhart@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative haemostatic efficacy described in real life with ELOCTA® and ALPROLIX® in haemophilia A and B patients. Haemostatic efficacy is defined by excellent, good, fair, poor. (time frame: 15 days post-surgery). 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 6 Dec 2023.