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COMPLETED Phase 3

An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

NCT00945906 · View on ClinicalTrials.gov ↗

Study Summary

Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual clotting process, thereby preventing bleeding. In this study, patients will be treated with FXIII Concentrate (Human) and followed closely to determine that they receive the dose of FXIII Concentrate (Human) that will best minimize the chance of bruising and bleeding. The purpose of the study is to provide FXIII Concentrate (Human) to patients until the product becomes commercially available in the United States.

Conditions Studied

Interventions

  • BIOLOGICAL FXIII Concentrate (Human) (FXIII)

Study Locations (20)

California

  • Study Site — Oakland
  • Study Site — Orange
  • Study Site — San Francisco
  • Study Site — Stockton

Florida

  • Study Site — Fort Myers
  • Study Site — Miami
  • Study Site — St. Petersburg

Michigan

  • Study Site — Ann Arbor
  • Study Site — Detroit

New York

  • Study Site — Albany
  • Study Site — New York

Alabama

  • Study Site — Dothan

Louisiana

  • Study Site — New Orleans

Massachusetts

  • Study Site — Boston

Missouri

  • Study Site — Kansas City

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2009-09
Est. Completion 2011-08
Phase Phase 3

Sponsor

CSL Behring

85 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00945906

The ClinicalTrials.gov registry entry for NCT00945906 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Factor XIII Deficiency appearing as the primary indexed condition, and to 1 intervention — of which FXIII Concentrate (Human) (FXIII) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00945906 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00945906 about?

NCT00945906 is a clinical study titled "An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency". Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual clotting process, thereby...

What is the current status of trial NCT00945906?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2009-09. Estimated completion is 2011-08.

What conditions does trial NCT00945906 study?

This clinical trial studies the following conditions: Factor XIII Deficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00945906?

The interventions under investigation include: FXIII Concentrate (Human) (FXIII) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00945906?

This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00945906 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial