Severe HemophiliaNCT02324517
Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders
An observational study of Severe Hemophilia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. Read more about this study
- Who is it for?
- Ages 6 months to 90 years
- Conditions the study is for
- Severe Hemophilia
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Jun 2017
- 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 6 months to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with coagulopathies (see brief description)
Who may be able to join
- Informed consent
- Validated coagulation disorder
Who cannot join
- Not consenting to participate
- Multiple coagulopathies and comorbidities
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Mediacl Center
Ramat Gan, 52621
GITA VEIBER, Gita.veiber@sheba.health.gov.il
Gili Kenet, MD
About this study
Official title: Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders, Including Hemophilia With Inhibitors
Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. In this study blood sampled from patients with bleeding disorders will be evaluated applying ex- vivo spiking assays with various coagulation concentrates to potentially address the feasibility of replacement /bypass agents/ combined therapy for future bleeding episodes. Patients that will be further treated by any regimen potentially suggested (as standard care- not within trial) will be thereafter followed , including repeated lab studies to assess the impact of therapy upon hemostasis.
- Conditions
- Severe Hemophilia
- Keywords
- response to various potential therapies as managed by lab assays
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemophilia | Patients with Hemophilia A OR B | |
| inhibitor patients | Hemophilia or FXI def with inhibitors | |
| anticoagulants | patients under therapy with various anticoagulant drugs | |
| thrombocytopenia | patients with ITP, chronic thrombocytopenia, chemotherapy induced thrombocytopenia | |
| platelet function disorders | Glanzmann, Bernard Soulier, antiplatelet therapy | |
| Fibrinogen disordsers | hyperfibrinogenemia, hypofibrinogenemia, dysfibrinogenemia | |
| acquired hemophilia | patients with autoimmune Ab's to FVIII | |
| RBD | FXIII DEF, FV+FVIII DEF, FVII DEF, FV DEF | |
| THROMBOLYTICS | Patients treated by thrombolytic agents | |
| Hypercoag | thrombophilias, thrombosis- inc under therapy, acquired high thrombotic risk (eg: cancer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombin Generation Parameters pre and post therapy / spiking assays
Thrombin Generation Parameters (Peak height, ETP) before and after spiking assays with procoagulant drugs will be compared for each patient separately and within each group of patients diagnosed with similar coagulation disorder.
Measured: 1 year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startMar 2010
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe HemophiliaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Gila Kenet MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324517
- Sponsor's protocol ID
- SHEBA-09-7563-GK-CTIL
- Status last verified
- Dec 2014
- First submitted
- 30 Nov 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders, Including Hemophilia With Inhibitors
- ClinicalTrials.gov ID
- NCT02324517
- Acronym / sponsor ID
- SHEBA-09-7563-GK-CTIL
- Conditions
- Severe Hemophilia
- Keywords
- response to various potential therapies as managed by lab assays
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2010
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Dec 2014 (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.
Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. In this study blood sampled from patients with bleeding disorders will be evaluated applying ex- vivo spiking assays with various coagulation concentrates to potentially address the feasibility of replacement /bypass agents/ combined therapy for future bleeding episodes. Patients that will be further treated by any regimen potentially suggested (as standard care- not within trial) will be thereafter followed , including repeated lab studies to assess the impact of therapy upon hemostasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Hemophilia | – | –Patients with Hemophilia A OR B |
| inhibitor patients | – | –Hemophilia or FXI def with inhibitors |
| anticoagulants | – | –patients under therapy with various anticoagulant drugs |
| thrombocytopenia | – | –patients with ITP, chronic thrombocytopenia, chemotherapy induced thrombocytopenia |
| platelet function disorders | – | –Glanzmann, Bernard Soulier, antiplatelet therapy |
| Fibrinogen disordsers | – | –hyperfibrinogenemia, hypofibrinogenemia, dysfibrinogenemia |
| acquired hemophilia | – | –patients with autoimmune Ab's to FVIII |
| RBD | – | –FXIII DEF, FV+FVIII DEF, FVII DEF, FV DEF |
| THROMBOLYTICS | – | –Patients treated by thrombolytic agents |
| Hypercoag | – | –thrombophilias, thrombosis- inc under therapy, acquired high thrombotic risk (eg: cancer) |
Who may qualify
- Ages
- 6 months to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with coagulopathies (see brief description)
Key inclusion criteria (2 listed)
- Informed consent
- Validated coagulation disorder
Key exclusion criteria (2 listed)
- Not consenting to participate
- Multiple coagulopathies and comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thrombin Generation Parameters pre and post therapy / spiking assays
Time frame: 1 year from enrollment
Thrombin Generation Parameters (Peak height, ETP) before and after spiking assays with procoagulant drugs will be compared for each patient separately and within each group of patients diagnosed with similar coagulation disorder.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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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 Severe Hemophilia, run by Sheba Medical Center at 1 site 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 2 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 24 Dec 2014. 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 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 Gili Kenet, MD (+972526666385, gili.kenet@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombin Generation Parameters pre and post therapy / spiking assays (time frame: 1 year from enrollment). 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 24 Dec 2014.