NCT01234545

Brief Summary

This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
5 countries

5 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

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

1.5 years

First QC Date

November 3, 2010

Last Update Submit

November 13, 2014

Conditions

Congenital Bleeding DisorderHaemophilia AHaemophilia B

Outcome Measures

Primary Outcomes (3)

  • Number of bleeds managed at home

    Month 8

  • Number of treatments resulting in the control of bleeding episode

    within 9 hours after the first injection of study product

  • Number of treatments resulting in effective pain relief

    within 9 hours after the first injection of study product

Secondary Outcomes (2)

  • Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home

    Month 8

  • Proportion of patients who used their entire treatment at home

    Month 8

Study Arms (1)

A

Drug: activated recombinant human factor VII

Interventions

activated recombinant human factor VIIDRUG

Prescription is done at the discretion of the prescribing physician as part of normal clinical routine

A

Eligibility Criteria

Age2 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with congenital haemophilia and inhibitors to Factor VIII or IX.

You may qualify if:

  • Patients with congenital haemophilia and inhibitors to factor VIII or IX
  • Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle

You may not qualify if:

  • Known or suspected allergy to study product(s) or related products
  • Clinically relevant coagulation disorders other than congenital haemophilia A or B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Algiers, 16035, Algeria

Location

Unknown Facility

Casablanca, 20000, Morocco

Location

Unknown Facility

Muscat, Oman

Location

Unknown Facility

Riyadh, 3542, Saudi Arabia

Location

Unknown Facility

Dubai, United Arab Emirates

Location

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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2010

First Posted

November 4, 2010

Study Start

October 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations

AL(1)MO(1)AE(1)OM(1)SA(1)