Protein C DeficiencyNCT01127529
Ceprotin Treatment Registry
An observational study of Protein C Deficiency, run by Baxalta now part of Shire at 28 sites in 6 countries.
Trial summary
The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Protein C Deficiency
- What is being tested?
- Protein C Concentrate (Human)
- How many people
- 43 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 23 Jun 2010to 22 Jun 2015
- 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: Registry participants will be identified by working with Hemophilia Treatment Centers and Thrombosis Centers known to have participants with severe congenital Protein C deficiency, as well as by working with centers that use CEPROTIN in emergency care situations.
Who may be able to join
- Participants for whom CEPROTIN therapy has been indicated and meeting the following criteria may be enrolled in this study:
- Signed and dated informed consent from either the participant or the participant's legally authorized representative prior to enrollment, as applicable
- Males and females of any age, including neonates, children, adolescents and adults
- Participant who received CEPROTIN or is initiating/receiving CEPROTIN treatment
Who cannot join
- None
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States12 sites
Study site
Aurora, Colorado
Study site
Boston, Massachusetts
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Dayton, Ohio
Study site
Fort Worth, Texas
Study site
Grand Rapids, Michigan
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Lebanon, New Hampshire
Study site
Orange, California
Study site
Phoenix, Arizona
Germany6 sites
Study site
Bonn
Study site
Frankfurt
Study site
Hanover
Study site
Heidelberg
Study site
Magdeburg
Study site
Magstadt
Italy4 sites
Study site
Milan
Study site
Palermo
Study site
Rome
Study site
Vicenza
United Kingdom3 sites
Study site
Bradford
Study site
London
Study site
Manchester
About this study
The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.
- Conditions
- Protein C Deficiency
- Being tested
- Protein C Concentrate (Human)
- Medical subject headings
- Protein C Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein C Concentrate (Human)Biological
Also called Ceprotin
Commercially available Ceprotin will be prescribed, obtained and administered by the investigator according to local standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with severe congenital protein C deficiency | Registry subjects will be identified by working with Hemophilia Treatment Centers and Thrombosis Centers known to have subjects with severe congenital protein C deficiency, as well as by working with centers that use Ceprotin in emergency care situations. Receives: Biological: Protein C Concentrate (Human) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical diagnoses associated with Ceprotin treatment
Measured: 2 to 5 years, or until the Registry is terminated
Ceprotin treatment regimens
Measured: 2 to 5 years, or until the Registry is terminated
Safety information based on all serious adverse events (SAEs), related SAEs and related non-serious adverse events (AEs)
Measured: 2 to 5 years, or until the Registry is terminated
Secondary outcomes (2)
Treatment outcomes categorized by medical diagnosis
Evidence of halting or reversal of coagulopathy or thrombosis, end-organ damage, limb sparing, Length of Hospital Stay (LOS), and mortality
Measured: 2 to 5 years, or until the Registry is terminated
CEPROTIN use and treatment outcomes in pregnancy, labor and delivery, surgery and invasive procedures, different age groups, and, in the presence of pre-existing renal and/or hepatic dysfunction
Measured: 2 to 5 years, or until the Registry is terminated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study start23 Jun 2010
- Primary completion22 Jun 2015
- Study completion22 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein C 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG), American Thrombosis and Hemostasis Network
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127529
- Sponsor's protocol ID
- 400701
- Status last verified
- Mar 2021
- First submitted
- 16 Apr 2010
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceprotin Treatment Registry
- ClinicalTrials.gov ID
- NCT01127529
- Acronym / sponsor ID
- 400701
- Conditions
- Protein C Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Collaborators
- UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG), American Thrombosis and Hemostasis Network
- Study start
- 23 Jun 2010 (actual)
- Primary completion
- 22 Jun 2015 (actual)
- Study completion
- 22 Jun 2015 (actual)
- First posted
- 21 May 2010 (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 overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with severe congenital protein C deficiency | – | Biological: Protein C Concentrate (Human)Registry subjects will be identified by working with Hemophilia Treatment Centers and Thrombosis Centers known to have subjects with severe congenital protein C deficiency, as well as by working with centers that use Ceprotin in emergency care situations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Registry participants will be identified by working with Hemophilia Treatment Centers and Thrombosis Centers known to have participants with severe congenital Protein C deficiency, as well as by working with centers that use CEPROTIN in emergency care situations.
Key inclusion criteria (4 listed)
- Participants for whom CEPROTIN therapy has been indicated and meeting the following criteria may be enrolled in this study:
- Signed and dated informed consent from either the participant or the participant's legally authorized representative prior to enrollment, as applicable
- Males and females of any age, including neonates, children, adolescents and adults
- Participant who received CEPROTIN or is initiating/receiving CEPROTIN treatment
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 |
|---|---|---|
| Protein C Concentrate (Human)Also: CeprotinCommercially available Ceprotin will be prescribed, obtained and administered by the investigator according to local standard of care. | Biological | Subjects with severe congenital protein C deficiency |
Primary outcome
Medical diagnoses associated with Ceprotin treatment
Time frame: 2 to 5 years, or until the Registry is terminated
Ceprotin treatment regimens
Time frame: 2 to 5 years, or until the Registry is terminated
Safety information based on all serious adverse events (SAEs), related SAEs and related non-serious adverse events (AEs)
Time frame: 2 to 5 years, or until the Registry is terminated
2 secondary outcomes
Treatment outcomes categorized by medical diagnosis
Time frame: 2 to 5 years, or until the Registry is terminated
CEPROTIN use and treatment outcomes in pregnancy, labor and delivery, surgery and invasive procedures, different age groups, and, in the presence of pre-existing renal and/or hepatic dysfunction
Time frame: 2 to 5 years, or until the Registry is terminated
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 Mar 2021.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
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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.
Study Director study director
Takeda
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Protein C Deficiency, run by Baxalta now part of Shire at 28 sites in 6 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 4 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 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Germany, Italy, United Kingdom, Austria and 1 more country. 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?
Medical diagnoses associated with Ceprotin treatment (time frame: 2 to 5 years, or until the Registry is terminated). The study lists 3 primary outcomes in all. 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 Mar 2021.