NCT01312636

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

3.5 years

First QC Date

March 2, 2011

Last Update Submit

October 17, 2014

Conditions

Congenital Bleeding DisorderCongenital FVII Deficiency

Outcome Measures

Primary Outcomes (1)

  • Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions

    once a year in years 1-4

Secondary Outcomes (2)

  • To assess the treatment evaluation for bleeding episodes

    year 1, year 4

  • To assess the course and outcome of pregnancy in women treated with novoseven

    until 1 month after giving birth

Study Arms (1)

A

Drug: activated recombinant human factor VII

Interventions

activated recombinant human factor VIIDRUG

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

A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All subjects with a FVII deficiency to whom activated recombinant human factor VII (NovoSeven®) is administered

You may qualify if:

  • Congenital FVII deficiency
  • Never been treated with NovoSeven® before
  • Patients already in treatment with NovoSeven®

You may not qualify if:

  • History of hypersensitivity to any of the components in NovoSeven®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, 1000005, Japan

Location

Related Publications (1)

  • Seita I, Kinai E. A multicenter, observational study to evaluate hemostasis following recombinant activated FVII treatment in patients in Japan with congenital factor VII deficiency. Blood Coagul Fibrinolysis. 2023 Jul 1;34(5):295-304. doi: 10.1097/MBC.0000000000001225. Epub 2023 Jun 23.

    PMID: 37395185DERIVED

Related Links

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 11, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations

JP(1)