Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)

NCT00139828 | Completed Phase 4

• 1 other identifier: KB2000.03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 7

Brief Summary

In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is evaluated in previous treated and untreated patients with severe, moderate or mild haemophilia B.

Conditions

Hemophilia B

Keywords

haemophilia B; factor IX; Product Surveillance, Postmarketing; plasma products

Outcome Measures

Primary Outcomes (3)

• Number of bleeding episodes (efficacy after administration)

  24 months

• Haematological variables and clinical chemistry (safety)

  24 months

• Adverse events (safety)

  24 months

Secondary Outcomes (1)

• Occurrence of antibodies to factor IX

  24 months

Study Arms (1)

A

OTHER

The amount of Nonafact® to be administered and the frequency of treatment is based on the SmPC and should always be determined on the basis of the clinical effectiveness in the individual patient

Drug: human coagulation Factor IX

Interventions

human coagulation Factor IX DRUG

Also known as: Nonafact

A

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers of Haemophilia B and Haemophilia B Leyden
• Tested positive for HAV and HBV antibodies, induced by infection or vaccination, and negative for HBsAg
• Informed consent signed by the patients or his legally accepted representative

You may not qualify if:

• Tested negative for HAV and HBV antibodies

Sponsors & Collaborators

• Prothya Biosolutions: lead

Study Sites (7)

Academic Medical Centre

Amsterdam, 1105 AZ, Netherlands

Location

Kennemer Gasthuis

Haarlem, Netherlands

Location

LUMC

Leiden, 2333 ZA, Netherlands

Location

UMC St. Radboud

Nijmegen, 6525 GA, Netherlands

Location

Erasmus Medical Centre

Rotterdam, 3015 GD, Netherlands

Location

Leyenburg Hospital

The Hague, 2545 CH, Netherlands

Location

Van Creveldkliniek

Utrecht, 3584CX, Netherlands

Location

MeSH Terms

Conditions

Hemophilia B

Interventions

Factor IX

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

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• E P Mauser-Bunschoten, MD, PdD

  UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: August 31, 2005
• Study Start: May 1, 2003
• Study Completion: February 1, 2007
• Last Updated: August 30, 2007

Record last verified: 2007-08

Locations

NL (7)