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NCT01959555 Clinical Trial

Project to Update the Study of Congenital Haemophilia in Spain

Congenital Bleeding Disorder Clinical Trial

— PUCHS  

Official title:
Project to Update the Study of Congenital Haemophilia in Spain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01959555
Other study ID # HAEM-4076
Secondary ID U1111-1136-7052N
Status Completed
Phase N/A
First received October 8, 2013
Last updated November 27, 2015
Start date March 2014
Est. completion date December 2014

Study information
Verified date November 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Observational

Clinical Trial Summary

This study is conducted in Europe. The aim of the study is to update the knowledge about the prevalence and severity of congenital haemophilia (A and B) in Spain.

Recruitment information / eligibility
Status Completed
Enrollment 1157
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)

- Male patients of any age diagnosed with congenital haemophilia A or B who visited their HTC at least once during the period of January 2013 to December 2013

Exclusion Criteria:

- Previous participation in this study

- Female patients

- Acquired haemophilia

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• No treatment given
Patients will not be treated with any specific product. Data collection only.

Locations
Country Name City State
n/a

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

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of congenital haemophilia A and B in Spain in 2013, described as proportion (%) of patients in the total population (extracted from the last available census of the Spanish population for the regions considered for the study) Assessed at study visit (day 1) No
Primary Severity (mild, moderate or severe) of congenital haemophilia A and B in Spain during 2013, described as proportion (%) per category of the total number of patients with haemophilia A or B Assessed at study visit (day 1) No
Secondary Mean current age at the time of visit to the HTC in 2013 Assessed at study visit (day 1) No
Secondary Mean age at diagnosis Assessed at study visit (day 1) No
Secondary Proportion (%) of patients with/without genetic screening performed Assessed at study visit (day 1) No
Secondary Proportion (%) of patients who needed support of a reference Haemophilia Healthcare Centre in 2013 Assessed at study visit (day 1) No
Secondary Proportion (%) of patients who received plasmatic or recombinant treatment Assessed at study visit (day 1) No
Secondary Proportion (%) of patients who received on demand or prophylaxis treatment Assessed at study visit (day 1) No
Secondary Mean number of bleeding episodes Assessed at study visit (day 1) No
Secondary Mean number of joint bleeds Assessed at study visit (day 1) No
Secondary Proportion (%) of patients with established arthropathy Assessed at study visit (day 1) No
Secondary Proportion (%) of patients with infectious complications Assessed at study visit (day 1) No
Secondary Proportion (%) of patients with HIV (Human immunodeficiency virus) Assessed at study visit (day 1) No
Secondary Proportion (%) of patients with presence of inhibitors Assessed at study visit (day 1) No
Secondary Proportion (%) of patients with immune tolerance induction treatment performed Assessed at study visit (day 1) No
Secondary Total number of surgery interventions performed ThAssessed at study visit (day 1) No
Secondary Proportion (%) of patients with quality of life questionnaire (QoLQ) performed in 2013 Assessed at study visit (day 1) No
Secondary Mean number of days of absenteeism to school/university in children and adolescents in 2013 Assessed at study visit (day 1) No
Secondary Mean number of days of absenteeism from work in 2013 Assessed at study visit (day 1) No
Secondary Proportion (%) of patients with treatment administered at home Assessed at study visit (day 1) No
See also
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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 NCT01220141 - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B N/A

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