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

NCT01220141 | Completed

• 2 other identifiers: NN7025-3601U1111-1116-2012
• Study Type: observational
• Target: 51
• Locations: 14 countries
• Sites: 14

Brief 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).

Conditions

Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Outcome Measures

Primary Outcomes (1)

• Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory

  after 25 exposure days

Secondary Outcomes (1)

• Adverse events reported as potentially related to activated recombinant human factor VII

  after 25 exposure days

Study Arms (1)

A

Drug: activated recombinant human factor VII

Interventions

activated recombinant human factor VII DRUG

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.

A

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male patients with haemophilia A or B with inhibitors treated with room temperature stable NovoSeven® (activated recombinant human factor VII).

You may qualify if:

• Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX
• Treated with room temperature stable NovoSeven®

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (14)

Unknown Facility

Prov. de Buenos Aires, B1636DSU, Argentina

Location

Unknown Facility

Vienna, A-1010, Austria

Location

Unknown Facility

Brussels, 1070, Belgium

Location

Unknown Facility

Paris La Défense Cedex, 92932, France

Location

Unknown Facility

Mainz, 55127, Germany

Location

Unknown Facility

Budapest, 1025, Hungary

Location

Unknown Facility

Tehran, Iran

Location

Unknown Facility

Dublin, Ireland

Location

Unknown Facility

Rome, 00144, Italy

Location

Unknown Facility

Warsaw, PL-02-274, Poland

Location

Unknown Facility

Paço de Arcos, 2780-730, Portugal

Location

Unknown Facility

Bratislava, 811 05, Slovakia

Location

Unknown Facility

Malmo, 202 15, Sweden

Location

Unknown Facility

Crawley, RH11 9RT, United Kingdom

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic 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: October 12, 2010
• First Posted: October 13, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

BE (1); IT (1); IE (1); DE (1); AR (1); PT (1); HU (1); PL (1); AU (1); SL (1); GB (1); IR (1); FR (1); SE (1)