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Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency

NCT01312636 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2014-10-20

No results posted yet for this study

Summary

This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.

Conditions

  • Congenital Bleeding Disorder
  • Congenital FVII Deficiency

Interventions

DRUG

activated recombinant human factor VII

Data will be collected at the baseline visit and approximately once a year until end of study.

Sponsors & Collaborators

Principal Investigators

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

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Japan

Study Locations

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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 NCT01312636 on ClinicalTrials.gov