CompletedPhase 1

Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

United Kingdom50 participantsStarted 2003-01

Plain-language summary

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

Who can participate

Age range

18 Years – 65 Years

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: * Normal platelet count and clotting parameters * Adequate renal and hepatic function * If female and of child-bearing potential, negative serum pregnancy test within 21 days of enrollment and a negative urine pregnancy test on admission to the clinical research unit * If a sexually active male or a sexually active female of child-bearing potential,agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits * Negative drug and alcohol screens Exclusion Criteria: * Known antibodies or hypersensitivity to FXIII * Known bleeding or hematologic disorder * Known allergy to yeast * Receipt of blood products within 30 days of screening * Donation of blood within 30 days prior to enrollment * Any surgical procedure in the 30 days prior to enrollment * Previous history of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus * Receipt of treatment with any experimental agent within 30 days of study enrollment

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

Incidence of adverse events

Timeframe: Days 0-28

Trial details

NCT IDNCT01847989

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-05

View on ClinicalTrials.gov More Congenital Bleeding Disorder trials

Who can participate

Age range

18 Years – 65 Years

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.