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NCT01220141 Clinical Trial

Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B

Congenital Bleeding Disorder Clinical Trial

Official title:
Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01220141
Other study ID # NN7025-3601
Secondary ID U1111-1116-2012
Status Completed
Phase N/A
First received October 12, 2010
Last updated April 15, 2015
Start date November 2010
Est. completion date March 2015

Study information
Verified date April 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustria: Not required for observational study in AustriaBelgium: Not required for observational study in BelgiumFrance: Not required for observational studyGermany: Not required for observational studyHungary: Not required for observational studyIran: Ministry of Health and Medical EducationIreland: Not required for observational studyItaly: Not required for observational studyPoland: Not required for observational studyPortugal: Not required for observational studySlovakia: State Institute for Drug ControlSweden: Not required for observational studyUnited Kingdom: Not required for observational study
Study type Observational

Clinical Trial Summary

This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX

- Treated with room temperature stable NovoSeven®

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• activated recombinant human factor VII
Administration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country.

Locations
Country Name City State
n/a

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

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  France,  Germany,  Hungary,  Iran, Islamic Republic of,  Ireland,  Italy,  Poland,  Portugal,  Slovakia,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory after 25 exposure days No
Secondary Adverse events reported as potentially related to activated recombinant human factor VII after 25 exposure days 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 NCT01238367 - A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543 Phase 1

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