Factor 10 DeficiencyNCT03161626
Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery
An observational study of Factor 10 Deficiency, run by Bio Products Laboratory at 3 sites in United States.
Trial summary
This is a non-interventional, multicenter, post-marketing registry study in three patients with moderate or severe hereditary FX deficiency, to assess Coagadex administered peri-operatively for hemostatic cover in major surgery during routine post-marketing use. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Factor 10 Deficiency
- What is being tested?
- Coagadex
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Feb 2018to 13 Oct 2021
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with moderate or severe hereditary Factor X deficiency undergoing major surgery.
Who may be able to join
- Patients >12 years of age with severe or moderate hereditary FX deficiency. Severe is defined as <1 IU/dL and moderate as 1 to 5 IU/dL (3)
- Patients who have given written informed consent (for sites in the USA this will include the Health Insurance Portability and Accountability Act (HIPAA) authorization statement), OR, in the case of 12-18 year olds, written informed consent from the parents/ guardians and where appropriate assent from the child
- Patients requiring major surgery. Major surgery is defined as procedures typically requiring:
- full anesthesia or regional anesthesia, e.g. epidural or spinal and
- involving the opening of major cavities such as thoracic, abdominal surgery; orthopedic surgery, and Caesarean section (C-section) and
- requiring at least one overnight stay in hospital (16)
Who cannot join
- Patients known to be pregnant, unless the surgery is C-section.
- Patients who participated in a clinical study trial in the last 30 days prior to study enrolment, except if they have been involved in another study involving Coagadex.
- Patients with a known history of inhibitor development to FX.
- Patients who are required or expected to take other factor X-containing medications during or after surgery.
- Patients with existing known thrombocytopenia (platelets < 50 x 109/L).
- Patients with existing known clinically significant renal disease (creatinine >200 µmol/L).
Show all 11Show fewer
- Patients with existing known clinically significant liver disease (ALT levels greater than three times the upper limit of normal).
- Patients with existing known other coagulopathy or thrombophilia.
- Patients with a known intolerance or allergy to Coagadex or its excipients.
- Patients known to have abused chemicals or drugs within the past 12 months.
- Patients with a history of unreliability or non-cooperation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida Health
Gainesville, Florida, 32610
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Tulane University Hospitals and Clinics
New Orleans, Louisiana, 70112
About this study
Official title: A Multicenter, Post-Marketing Registry Study of COAGADEX® in the Peri-operative Management of Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery
This is a non-interventional, multicenter, post-marketing registry study in three patients with moderate or severe hereditary FX deficiency, to assess Coagadex administered peri-operatively for hemostatic cover in major surgery during routine post-marketing use.
Read the detailed description
The primary objective is to collect additional surgical data on the clinical effectiveness of Coagadex, in a post-marketing environment, for peri-operative hemostatic cover during major surgery in patients with moderate or severe hereditary factor X (FX) deficiency.
The secondary objective is to review safety data on Coagadex through the collection of any Adverse Drug Reactions (ADRs) from the first dose of Coagadex in the hospital prior to the surgical procedure until the first follow-up after discharge (i.e., follow-up completed) and Serious ADRs up until the post-operative care follow-up has been completed. Data on any deaths and pregnancies reported within this time period will be collected.
- Conditions
- Factor 10 Deficiency
- Being tested
- Coagadex
- Medical subject headings
- Factor X Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoagadexDrug
Also called Factor X
Plasma-driven blood coagulation factor X concentration
| Study group | Role | What they receive |
|---|---|---|
| Moderate to Severe Factor X Deficiency | Not described Receives: Drug: Coagadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective surgical data collection
Blood loss (mL)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start27 Feb 2018
- Primary completion13 Oct 2021
- Study completion13 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Factor 10 DeficiencyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio Products Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161626
- Sponsor's protocol ID
- Ten06
- Status last verified
- Nov 2021
- First submitted
- 18 May 2017
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Post-Marketing Registry Study of COAGADEX® in the Peri-operative Management of Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT03161626
- Acronym / sponsor ID
- Ten06
- Conditions
- Factor 10 Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bio Products LaboratoryUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 22 May 2017 (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.
This is a non-interventional, multicenter, post-marketing registry study in three patients with moderate or severe hereditary FX deficiency, to assess Coagadex administered peri-operatively for hemostatic cover in major surgery during routine post-marketing use.
Detailed description
The primary objective is to collect additional surgical data on the clinical effectiveness of Coagadex, in a post-marketing environment, for peri-operative hemostatic cover during major surgery in patients with moderate or severe hereditary factor X (FX) deficiency.
The secondary objective is to review safety data on Coagadex through the collection of any Adverse Drug Reactions (ADRs) from the first dose of Coagadex in the hospital prior to the surgical procedure until the first follow-up after discharge (i.e., follow-up completed) and Serious ADRs up until the post-operative care follow-up has been completed. Data on any deaths and pregnancies reported within this time period will be collected.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate to Severe Factor X Deficiency | – | Drug: Coagadex |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with moderate or severe hereditary Factor X deficiency undergoing major surgery.
Key inclusion criteria (6 listed)
- Patients >12 years of age with severe or moderate hereditary FX deficiency. Severe is defined as <1 IU/dL and moderate as 1 to 5 IU/dL (3)
- Patients who have given written informed consent (for sites in the USA this will include the Health Insurance Portability and Accountability Act (HIPAA) authorization statement), OR, in the case of 12-18 year olds, written informed consent from the parents/ guardians and where appropriate assent from the child
- Patients requiring major surgery. Major surgery is defined as procedures typically requiring:
Key exclusion criteria (11 listed)
- Patients known to be pregnant, unless the surgery is C-section.
- Patients who participated in a clinical study trial in the last 30 days prior to study enrolment, except if they have been involved in another study involving Coagadex.
- Patients with a known history of inhibitor development to FX.
- Patients who are required or expected to take other factor X-containing medications during or after surgery.
- Patients with existing known thrombocytopenia (platelets < 50 x 109/L).
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 |
|---|---|---|
| CoagadexAlso: Factor XPlasma-driven blood coagulation factor X concentration | Drug | Moderate to Severe Factor X Deficiency |
Primary outcome
Retrospective surgical data collection
Time frame: 12 months
Blood loss (mL)
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 12 Nov 2021.
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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 Factor 10 Deficiency, run by Bio Products Laboratory at 3 sites 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 11 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 12 Nov 2021. 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 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?
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?
Retrospective surgical data collection (time frame: 12 months). 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 12 Nov 2021.