Hemophilia CrFVIIaNCT01538160
A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery
A study testing recombinant factor VIIa in people with Hemophilia C, run by Sheba Medical Center at 3 sites in Israel.
Trial summary
Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemophilia C
- What is being tested?
- recombinant factor VIIa
- How many people
- 15 participants
- Where
- 3 sitesIsrael
- Study dates
- Feb 2012to Jul 2015
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with severe factor XI deficiency who will give informed consent to participate in the study
Who cannot join
- patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke
- Patients who required aorto-coronary bypass or any vascular surgery
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Ophira Salomon
Ramat Gan
Ophira salomon, MD, 01197235302104, ophiras@sheba.health.gov.il
Uri Seligsohn, MD, 01197235302104, Uri.Seligson@sheba.health.gov.il
Sheba Medical Center
Ramat Gan
Sheba Medical Center
Tel Hashomer, Ramat-Gan
About this study
Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.
Read the detailed description
Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.
- Conditions
- Hemophilia C
- Being tested
- recombinant factor VIIa
- Keywords
- recombinant factor VIIa, factor XI deficiency
- Medical subject headings
- Factor XI Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant factor VIIaDrug
single dose of 20ug/kg of recombinant factor VIIa along with tranexamic acid of 4 gram a day for 7 days following surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency
End point to be assessed the degree of bleeding following major operation under rFVIIa
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophilia CStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538160
- Sponsor's protocol ID
- SHEBA-11-8657-OS-CTIL
- Acronym
- rFVIIa
- Status last verified
- Feb 2012
- First submitted
- 19 Jan 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Salomon et al presented at ASH 2008 entitled
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery
- ClinicalTrials.gov ID
- NCT01538160
- Acronym / sponsor ID
- rFVIIa / SHEBA-11-8657-OS-CTIL
- Conditions
- Hemophilia C
- Keywords
- recombinant factor VIIa, factor XI deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Feb 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 23 Feb 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.
Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.
Detailed description
Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with severe factor XI deficiency who will give informed consent to participate in the study
Key exclusion criteria (2 listed)
- patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke
- Patients who required aorto-coronary bypass or any vascular surgery
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 VIIasingle dose of 20ug/kg of recombinant factor VIIa along with tranexamic acid of 4 gram a day for 7 days following surgery | Drug | – |
Primary outcome
Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency
Time frame: 1 week
End point to be assessed the degree of bleeding following major operation under rFVIIa
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
- BackgroundSalomon et al presented at ASH 2008 entitled
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recombinant factor VIIa in people with Hemophilia C, run by Sheba Medical Center at 3 sites in Israel.
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 2 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 Feb 2012. 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 Israel. 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 Ophira Salomon, MD (97235302104, ophiras@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538160, which also lists 1 linked publication.
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 Feb 2012.