CompletedPhase 2

Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

United States, Bulgaria, India22 participantsStarted 2013-06

Plain-language summary

The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency

Who can participate

Age range

12 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: * Age ≥ 12 years. * Documented congenital fibrinogen deficiency (afibrinogenemia). Exclusion Criteria: * Life expectancy \> 6 month. * Bleeding disorder other than congenital fibrinogen deficiency. * Presence or history of hypersensitivity to study medication. * Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment. * Presence or history of arterial thrombosis with 1 year prior to enrollment. * Hypersensitivity to human plasma products. * Acute bleeding. * Pregnant or currently breast-feeding women. * Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery (if available). * Blood or plasma donation in the 3 months prior to enrollment. * Human immunodeficiency virus (HIV) positive with a viral load \> 200 particles/µl or \> 400000 copies/mL. * End-stage liver disease. * History of oesophageal varicose bleeding.

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

Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized

Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment

Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion

Timeframe: 1 hour post-treatment

Trial details

NCT IDNCT01575756

SponsorOctapharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-01

Results submitted2016-10-05

View on ClinicalTrials.gov More Congenital Fibrinogen Deficiency trials