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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01269138
Other study ID # STERProtocol7.0
Secondary ID
Status Completed
Phase N/A
First received December 17, 2010
Last updated November 26, 2012
Start date January 2007
Est. completion date November 2012

Study information

Verified date November 2012
Source University of L'Aquila
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines AgencyUnited States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

FVII deficiency is a rare coagulation disorder. A limited number of patients are found in most treatment centres and countries. Treatment demands vary considerably amongst FVII deficient patients. Therefore, regular clinical studies will meet with recruitment problems in this particular patient population. The present study intends to elucidate the bleeding patterns in a well-defined collective of FVII deficiency patients who are carefully characterised, to document the actual use of different treatment modalities in different subgroups and to evaluate the efficacy and safety of current available treatment modalities in bleedings, surgery and prophylaxis. The purpose is to gain some evidence based knowledge of treatment of patients with FVII deficiency - an area where treatment decisions are made more on personal clinical experience than on consolidated clinical evidence.

This study intends to register treatment practices as they are actually performed - in a structured and documented way.


Description:

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Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
plasma derived Factor VII
Treatment of bleeding episodes,treatment during surgery and prophylaxis
recombinant FVIIa
Treatment of bleeding episodes,treatment during surgery and prophylaxis
Fresh Frozen Plasma
Treatment of bleeding episodes,treatment during surgery and prophylaxis
Activated Prothrombin Complex Concentrates
Treatment of bleeding episodes,treatment during surgery and prophylaxis
Virus Inactivated plasma
Treatment of bleeding episodes,treatment during surgery and prophylaxis

Locations

Country Name City State
Italy San Salvatore Hospital L'Aquila AQ

Sponsors (2)

Lead Sponsor Collaborator
University of L'Aquila TRIB s.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Factor VII levels To describe the treatment modalities and clinical and laboratory outcomes in:
-bleeding episodes - surgery - prophylaxis in a well defined, international cohort of FVII deficient patients characterised following the methodology used by the IF7SG.
Time 0 (before treatment), 15 minutes and 1 month after treatment Yes
Secondary Evaluation of Inhibitor Development To evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII. Monthly Yes
See also
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Completed NCT03079063 - Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven®, in Patients With Congenital Factor VII Deficiency Phase 3
Completed NCT03372993 - Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven
Completed NCT05651061 - A Phase I of SS109 in Hemophilia A or and B With Inhibitors Phase 1