Congenital Fibrinogen DeficiencyNCT02427217
An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
An observational study of Congenital Fibrinogen Deficiency, run by CSL Behring at 11 sites in 2 countries.
Trial summary
This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Fibrinogen Deficiency
- What is being tested?
- FCH
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 7 May 2015to 6 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician.
Who may be able to join
- Male or female subjects of any age with a diagnosis of congenital fibrinogen deficiency.
- Have received FCH (Haemocomplettan® P or RiaSTAP®) for treatment of bleeding, surgery or prophylaxis.
Who cannot join
- None
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Canada8 sites
Study Site
Calgary, Alberta, T2N 2T9
Study Site
Edmonton, Alberta, T6G 2H7
Study Site
Halifax, Nova Scotia, B3H2Y9
Study Site
Hamilton, Ontario, L8S 3Z5
Study Site
Montreal, Quebec, H3T 1C5
Study Site
Toronto, Ontario, M5B 1W8
Study Site
Toronto, Ontario, M5G 1X8
Study Site
Winnipeg, Manitoba, R3E 0V9
United States3 sites
Study Site
Aurora, Colorado, 80045
Study Site
Durham, North Carolina, 27705
Study Site
Las Vegas, Nevada, 89109
About this study
Official title: A Multicenter Study on the Retrospective Safety and Efficacy of Fibrinogen Concentrate (Human) (FCH) for Routine Prophylaxis, Treatment of Bleeding or Surgery in Subjects With Congenital Fibrinogen Deficiency With a Prospective Followup Component
This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.
- Conditions
- Congenital Fibrinogen Deficiency
- Being tested
- FCH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCHBiological
Also called Haemocomplettan® P, RiaSTAP®
FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Fibrinogen Concentrate, Human (FCH) | A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician. Receives: Biological: FCH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving hemostatic efficacy - retrospective
The investigator's overall assessment of hemostatic efficacy of FCH from a review of the subject's historical records.
Measured: From the subject's first use of FCH, up to approximately 20 years.
Secondary outcomes (2)
Percentage of participants achieving hemostatic efficacy - prospective
The investigator's overall assessment of hemostatic efficacy of FCH during the prospective follow-up period.
Measured: Approximately 12 months
Percentage of participants with adverse events
Measured: Retrospective data collection is from the subject's first use of FCH (up to approximately 20 years); Prospective data collection is from the time of informed consent up to approximately 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start7 May 2015
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Fibrinogen DeficiencyStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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
- Other
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Program Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427217
- Sponsor's protocol ID
- BI3023_4003
- Status last verified
- Jan 2018
- First submitted
- 22 Apr 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on the Retrospective Safety and Efficacy of Fibrinogen Concentrate (Human) (FCH) for Routine Prophylaxis, Treatment of Bleeding or Surgery in Subjects With Congenital Fibrinogen Deficiency With a Prospective Followup Component
- ClinicalTrials.gov ID
- NCT02427217
- Acronym / sponsor ID
- BI3023_4003
- Conditions
- Congenital Fibrinogen Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 7 May 2015 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 27 Apr 2015 (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.
This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibrinogen Concentrate, Human (FCH) | – | Biological: FCHA cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician.
Key inclusion criteria (2 listed)
- Male or female subjects of any age with a diagnosis of congenital fibrinogen deficiency.
- Have received FCH (Haemocomplettan® P or RiaSTAP®) for treatment of bleeding, surgery or prophylaxis.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| FCHAlso: Haemocomplettan® P, RiaSTAP®FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion. | Biological | Fibrinogen Concentrate, Human (FCH) |
Primary outcome
Percentage of participants achieving hemostatic efficacy - retrospective
Time frame: From the subject's first use of FCH, up to approximately 20 years.
The investigator's overall assessment of hemostatic efficacy of FCH from a review of the subject's historical records.
2 secondary outcomes
Percentage of participants achieving hemostatic efficacy - prospective
Time frame: Approximately 12 months
Percentage of participants with adverse events
Time frame: Retrospective data collection is from the subject's first use of FCH (up to approximately 20 years); Prospective data collection is from the time of informed consent up to approximately 12 months.
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 17 Jan 2018.
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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.
Program Director study director
CSL Behring
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Fibrinogen Deficiency, run by CSL Behring at 11 sites in 2 countries.
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 1 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada, 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?
Percentage of participants achieving hemostatic efficacy - retrospective (time frame: From the subject's first use of FCH, up to approximately 20 years.). 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 17 Jan 2018.