Wound; Rupture, Surgery, Cesarean SectionEAPNCT01701947
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
A study testing Hemoleven in people with Wound; Rupture, Surgery, Cesarean Section and Postpartum Hemorrhage, run by Laboratoire français de Fractionnement et de Biotechnologies at 1 site in United States.
Trial summary
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of administering selectively the missing factor outweigh the potential risks associated with… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- What is being tested?
- Hemoleven
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 months and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Severe inherited factor XI deficiency (FXI:C < 0.20 IU/mL i.e. <20 %)
- Patient older than 6 months old and weight at least 8 kg
- Known personal bleeding history
- Patient requiring FXI replacement therapy when oral antifibrinolytic agents alone or other means are ineffective or are contraindicated
- Scheduled to undergo an elective surgical procedure (including caesarean section) for which the patient requires hemostasis prophylaxis, which in the case of caesarean section is due to a history of postpartum bleeding, OR vaginal delivery for which the patient requires hemostasis prophylaxis due to a history of postpartum hemorrhage
- Patient/guardian provides signed and dated Informed Consent for 'HEMOLEVEN Expanded Access Program' prior to entry into the program
Who cannot join
- Personal history of thromboembolic events
- Underlying cardiopulmonary disease of NYHA Class III or greater
- History of severe reaction to any component of HEMOLEVEN notably to heparin or to its derivatives,including LMWH. Past history of serious type II heparin-induced thrombocytopenia (HIT)
- Presence of antibody to FXI in the past or currently
- Presence of any other condition that could contraindicate treatment with factor XI concentrate or lead the Physician/Investigator to believe treatment would not be in the best interest of the patient
- Positive, confirmed pregnancy test for patients undergoing elective surgery (not applicable for caesarean section and prevention in vaginal delivery)
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- Lactating woman.
- Of the seven exclusion criteria, the first four are included as a precautionary safety measure; the fifth is included to avoid a lack of efficacy.
- The two last criteria are included to minimize confounding influences on the evaluation of patient safety. Oral contraception is not mandatory as a pregnancy test is scheduled at inclusion visit and before surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center - Hemostasis & Thrombosis Ctr
Nashville, Tennessee, 37232-5505
About this study
Official title: HEMOLEVEN® Expanded Access Program for Prevention of Surgical and Postpartum Hemorrhage in Patients With Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of administering selectively the missing factor outweigh the potential risks associated with the administration of fresh-frozen plasma.
Read the detailed description
Many patients are asymptomatic until hemostatically challenged by surgery or trauma; so, the diagnosis is often made in late childhood or early adulthood but always after full liver maturation (i.e. 6 months) as reported by Andrew et al.
Spontaneous bleeding is rare, except menorrhagia, and bleeding occurs mainly after surgery or injury. Bleeding is observed mainly in surgical sites with high fibrinolytic activity such as mouth, nose, or the genitourinary tract.
Pregnancy, labor and delivery can also be challenging for women with FXI deficiency. In 1999 a study published in the American Journal of Hematology revealed that FXI levels are inconsistent during pregnancy. The incidence of postpartum hemorrhage is increased in women with factor XI deficiency. The incidence is 16% for the primary postpartum hemorrhage in FXI patients, compared with 5% in the general population. Moreover, the incidence is 24% for the secondary postpartum hemorrhage in comparison with that in the general obstetric population (0.7%). The authors recommend that FXI levels be obtained during the initial visit and monitored during the woman's third trimester. For all of these reasons it is important for women who suspect they might have a FXI deficiency to be tested and diagnosed before pregnancy.
Severe factor XI deficiency is defined by levels of <0.20 IU/mL. Such individuals have a high probability of post-operative hemorrhage. Individuals with levels between 0.20 IU/mL and the lower limit of the normal range, generally 0.65-0.80 IU/mL, are generally classified as having partial or mild deficiency with a lower risk of post-operative bleeding. Partial deficiency is being increasingly recognized following pre-operative tests or as a result of family screening. Thus partial factor XI deficiency is often diagnosed in asymptomatic individuals, creating management dilemmas because of the unpredictability of the bleeding risk. To differentiate an isolated or combined bleeding disorder in a patient with factor XI deficiency, other causes of bleeding should be investigated and excluded (e.g. von Willebrand disease, platelet disorders).
- Being tested
- Hemoleven
- Keywords
- Factor XI deficiency, EAP, postpartum hemorrhage, surgery, delivery, Child birth
- Medical subject headings
- Wounds and Injuries, Rupture, Postpartum Hemorrhage, Factor XI Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemolevenBiological
Also called Human Coagulation Factor XI
Replacement therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound; Rupture, Surgery, Cesarean SectionStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne T Neff, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701947
- Sponsor's protocol ID
- HM11-1102
- Acronym
- EAP
- Status last verified
- Aug 2013
- First submitted
- 3 Oct 2012
- Last updated
- 23 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEMOLEVEN® Expanded Access Program for Prevention of Surgical and Postpartum Hemorrhage in Patients With Severe Inherited Factor XI Deficiency
- ClinicalTrials.gov ID
- NCT01701947
- Acronym / sponsor ID
- EAP / HM11-1102
- Keywords
- Factor XI deficiency, EAP, postpartum hemorrhage, surgery, delivery, Child birth
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Laboratoire français de Fractionnement et de BiotechnologiesIndustry (pharma, biotech, devices)
- First posted
- 5 Oct 2012 (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.
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of administering selectively the missing factor outweigh the potential risks associated with the administration of fresh-frozen plasma.
Detailed description
Many patients are asymptomatic until hemostatically challenged by surgery or trauma; so, the diagnosis is often made in late childhood or early adulthood but always after full liver maturation (i.e. 6 months) as reported by Andrew et al.
Spontaneous bleeding is rare, except menorrhagia, and bleeding occurs mainly after surgery or injury. Bleeding is observed mainly in surgical sites with high fibrinolytic activity such as mouth, nose, or the genitourinary tract.
Pregnancy, labor and delivery can also be challenging for women with FXI deficiency. In 1999 a study published in the American Journal of Hematology revealed that FXI levels are inconsistent during pregnancy. The incidence of postpartum hemorrhage is increased in women with factor XI deficiency. The incidence is 16% for the primary postpartum hemorrhage in FXI patients, compared with 5% in the general population. Moreover, the incidence is 24% for the secondary postpartum hemorrhage in comparison with that in the general obstetric population (0.7%). The authors recommend that FXI levels be obtained during the initial visit and monitored during the woman's third trimester. For all of these reasons it is important for women who suspect they might have a FXI deficiency to be tested and diagnosed before pregnancy.
Severe factor XI deficiency is defined by levels of <0.20 IU/mL. Such individuals have a high probability of post-operative hemorrhage. Individuals with levels between 0.20 IU/mL and the lower limit of the normal range, generally 0.65-0.80 IU/mL, are generally classified as having partial or mild deficiency with a lower risk of post-operative bleeding. Partial deficiency is being increasingly recognized following pre-operative tests or as a result of family screening. Thus partial factor XI deficiency is often diagnosed in asymptomatic individuals, creating management dilemmas because of the unpredictability of the bleeding risk. To differentiate an isolated or combined bleeding disorder in a patient with factor XI deficiency, other causes of bleeding should be investigated and excluded (e.g. von Willebrand disease, platelet disorders).
Study design
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Severe inherited factor XI deficiency (FXI:C < 0.20 IU/mL i.e. <20 %)
- Patient older than 6 months old and weight at least 8 kg
- Known personal bleeding history
- Patient requiring FXI replacement therapy when oral antifibrinolytic agents alone or other means are ineffective or are contraindicated
- Scheduled to undergo an elective surgical procedure (including caesarean section) for which the patient requires hemostasis prophylaxis, which in the case of caesarean section is due to a history of postpartum bleeding, OR vaginal delivery for which the patient requires hemostasis prophylaxis due to a history of postpartum hemorrhage
Key exclusion criteria (9 listed)
- Personal history of thromboembolic events
- Underlying cardiopulmonary disease of NYHA Class III or greater
- History of severe reaction to any component of HEMOLEVEN notably to heparin or to its derivatives,including LMWH. Past history of serious type II heparin-induced thrombocytopenia (HIT)
- Presence of antibody to FXI in the past or currently
- Presence of any other condition that could contraindicate treatment with factor XI concentrate or lead the Physician/Investigator to believe treatment would not be in the best interest of the patient
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 |
|---|---|---|
| HemolevenAlso: Human Coagulation Factor XIReplacement therapy | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
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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.
Anne T Neff, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoleven in people with Wound; Rupture, Surgery, Cesarean Section and Postpartum Hemorrhage, run by Laboratoire français de Fractionnement et de Biotechnologies at 1 site in United States.
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 6 inclusion and 9 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 23 Aug 2013. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 23 Aug 2013.