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Treatment of Inherited Factor VII Deficiency

NCT01269138 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 223

Last updated 2012-11-27

No results posted yet for this study

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.

Conditions

  • Factor VII Deficiency

Interventions

DRUG

plasma derived Factor VII

Treatment of bleeding episodes,treatment during surgery and prophylaxis

DRUG

recombinant FVIIa

Treatment of bleeding episodes,treatment during surgery and prophylaxis

DRUG

Fresh Frozen Plasma

Treatment of bleeding episodes,treatment during surgery and prophylaxis

DRUG

Activated Prothrombin Complex Concentrates

Treatment of bleeding episodes,treatment during surgery and prophylaxis

DRUG

Virus Inactivated plasma

Treatment of bleeding episodes,treatment during surgery and prophylaxis

Sponsors & Collaborators

  • TRIB s.r.l.

    collaborator UNKNOWN

  • University of L'Aquila

    lead OTHER

Principal Investigators

  • guglielmo mariani, md · University of L'Aquila

Eligibility

Min Age
1 Day
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Completion
2012-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01269138 on ClinicalTrials.gov