CompletedNot Applicable

Ceprotin Treatment Registry

United States, Austria, Germany43 participantsStarted 2010-06-23

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Exclusion Criteria: * None

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Medical diagnoses associated with Ceprotin treatment

Timeframe: 2 to 5 years, or until the Registry is terminated

Ceprotin treatment regimens

Timeframe: 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)

Timeframe: 2 to 5 years, or until the Registry is terminated

Trial details

NCT IDNCT01127529

SponsorBaxalta now part of Shire

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-06-22

View on ClinicalTrials.gov More Protein C Deficiency trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Medical diagnoses associated with Ceprotin treatment

Timeframe: 2 to 5 years, or until the Registry is terminated

Ceprotin treatment regimens

Timeframe: 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)

Timeframe: 2 to 5 years, or until the Registry is terminated