NCT01503567

Brief Summary

This study is conducted in Africa and Asia. The aim of this study is to evaluate in the participating countries the orthopaedic status and the degree of arthropathy of severe haemophilia patients in general.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
4 countries

4 active sites

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

January 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 2, 2012

Last Update Submit

January 17, 2017

Conditions

Congenital Bleeding DisorderHaemophilia AHaemophilia A With InhibitorsHaemophilia BHaemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (2)

  • Type of haemophilia and inhibitor characteristics: Against FVIII or FIX; high or low titre; anamnestic response (high or low responder)

    After 6 months (recruitment and data collection)

  • Clinical (using Haemophilia joint score) and radiological (using Pettersson score) orthopaedic status of defined joints: Elbow, knees and ankles in relation to haemophilia A or B

    After 6 months (recruitment and data collection)

Secondary Outcomes (5)

  • Mean orthopaedic score in the 4 groups according to the Pettersson and Haemophilia joint scores

    After 6 months (recruitment and data collection)

  • Usage of anti haemophilic treatment in IU/kg

    During the last year preceding patient recruitment

  • Quality of Life - EQ-5D (Euro Quality - 5 Domains) questionnaire

    After 6 months (recruitment and data collection)

  • Economic aspects of the management of haemophiliacs and its burden on patient/family and community resources

    After 6 months (recruitment and data collection)

  • Living characteristics of the patient's household

    After 6 months (recruitment and data collection)

Study Arms (4)

Subjects 6 to 18 years old without inhibitors

Other: No treatment given

Subjects 6 to 18 years old with inhibitors

Other: No treatment given

Subjects above18 years old without inhibitors

Other: No treatment given

Subjects above 18 years old with inhibitors

Other: No treatment given

Interventions

No treatment givenOTHER

Subject will only fill out a questionaire

Subjects 6 to 18 years old with inhibitorsSubjects 6 to 18 years old without inhibitorsSubjects above 18 years old with inhibitorsSubjects above18 years old without inhibitors

Eligibility Criteria

Age6 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male patients at least 6 years old with severe congenital haemophilia A or B (FVIII or FIX activities below 1% or level below 1U dL\^-1) without inhibitor or with inhibitors against FVIII or FIX

You may qualify if:

  • Patient (and/or parents or the patient's legally acceptable representative, if applicable) must give signed and dated informed consent before enrolment in the study
  • Male patients at least 6 years old with diagnosis of severe congenital haemophilia A or B with or without inhibitors
  • Patients receiving on demand replacement factors/bypassing agents therapy

You may not qualify if:

  • Clinically relevant coagulation disorders other than congenital haemophilia A or B
  • Patients on currently active treatment for HCV (Hepatitis C Virus) or HIV (Human Immune Deficiency Virus) infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novo Nordisk Investigational Site

Bangalore, 560001, India

Location

Novo Nordisk Investigational Site

Casablanca, 20000, Morocco

Location

Novo Nordisk Investigational Site

Muscat, Oman

Location

Novo Nordisk Investigational Site

Sandton, 2146, South Africa

Location

Related Publications (1)

  • Gupta N, Belhani M, Benbouzid A, Andaloussi M El, Maani K, Mahlangu J, Wali Y, Saad HA, Fegoun SB el. The Haemocare Protocol - A composite method to measure the disease burden from Haemophilia in developing countries. European Hematology Association 2013; Country: Sweden City: Stockholm

    RESULT

Related Links

MeSH Terms

Conditions

Hemophilia AHemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 4, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

MO(1)ZA(1)OM(1)IN(1)