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Treatment of Congenital Factor VII Deficiency

NCT01779921 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 163

Last updated 2017-01-12

No results posted yet for this study

Summary

This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis.

Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.

Conditions

  • Congenital Bleeding Disorder
  • Congenital FVII Deficiency

Interventions

DRUG

activated recombinant human factor VII

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

DRUG

Fresh frozen plasma (Source unspecified)

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

DRUG

Plasma-derived FVII (LFB)

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

DRUG

Prothrombin Complex conc. (PCC)

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

DRUG

Plasma-derived FVII conc. (pdFVII Baxter)

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

DRUG

Plasma-derived FVII conc. (pdFVII PFL)

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States
  • France
  • Germany
  • Greece
  • Hong Kong
  • India
  • Iran
  • Israel
  • Italy
  • Pakistan
  • Serbia
  • Slovakia
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Venezuela

Study Locations

More Related Trials

Entities

Companies

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 NCT01779921 on ClinicalTrials.gov