CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Human Fibrinogen Concentratebiological
Likely dose
Human Fibrinogen Concentrate 70 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00496262
NCT00496262Phase 2Completed
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Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency

CSL Behring·interventional·Posted Jul 4, 2007·Updated Sep 15, 2016

In Brief

A Phase 2 clinical trial evaluating Human Fibrinogen Concentrate for Fibrinogen Deficiency. Completed, enrolled 15 participants across 15 sites in 2 countries.

Detailed Summary

This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness \[MCF\]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibrinogen concentrate was administered.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibrinogen Deficiency
CountriesItaly, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 4, 2007
Enrollment StartJul 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.0 years ago

Interventions

Human Fibrinogen Concentratebiological

Single intravenous infusion of 70 mg/kg body weight