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NCT01312636 Clinical Trial

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

Congenital Bleeding Disorder Clinical Trial

Official title:
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Congenital FVII Deficiency - Registry for All Treated Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01312636
Other study ID # F7HAEM-3862
Secondary ID U1111-1116-1529
Status Completed
Phase N/A
First received March 2, 2011
Last updated October 17, 2014
Start date March 2011
Est. completion date September 2014

Study information
Verified date October 2014
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Congenital FVII deficiency

- Never been treated with NovoSeven® before

- Patients already in treatment with NovoSeven®

Exclusion Criteria:

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Intervention

Drug:
• activated recombinant human factor VII
Data will be collected at the baseline visit and approximately once a year until end of study.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary To assess the treatment evaluation for bleeding episodes year 1, year 4 No
Secondary To assess the course and outcome of pregnancy in women treated with novoseven until 1 month after giving birth No
See also
  Status Clinical Trial Phase
Completed NCT00978380 - Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 Phase 3
Completed NCT02568202 - Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S) N/A
Completed NCT01949792 - A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors Phase 1
Completed NCT01205724 - Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A Phase 1
Completed NCT01562587 - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State Phase 1
Completed NCT00108797 - Trial of NovoSeven® in Haemophilia - Joint Bleeds Phase 4
Completed NCT01493778 - Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A Phase 3
Completed NCT02490787 - Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects Phase 1
Completed NCT00951405 - Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors Phase 2
Completed NCT01876745 - A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan N/A
Completed NCT02920398 - A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A Phase 1
Completed NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 Phase 3
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT01779921 - Treatment of Congenital Factor VII Deficiency N/A
Completed NCT01563471 - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers Phase 1
Completed NCT02941354 - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A Phase 1
Completed NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01230021 - Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency Phase 3

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