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NCT Number: NCT00139828

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

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.

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Key information

Conditions

Hemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Academic Medical Centre, Amsterdam, Netherlands

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About this study

The clinical efficacy and safety of Nonafact® has been shown in two pre-authorisation studies. Marketing authorisation for the EU was granted 3 July 2001. The Post Marketing Study, which evaluates the clinical efficacy, immunogenicity and safety of Nonafact®, is set up according to CPMP/BPWG /198/95, rev. 1 (Final, London, 19 October 2000) 'Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products'

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers of Haemophilia B and Haemophilia B Leyden
  • Above the age of six, at the moment of inclusion
  • 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

Exclusion criteria

  • Under the age of six, at the moment of inclusion
  • Tested negative for HAV and HBV antibodies

Treatment and study plan

human coagulation Factor IX

Drug

Other names: Nonafact

Primary outcomes

  1. Number of bleeding episodes (efficacy after administration)

    Time frame: 24 months

  2. Haematological variables and clinical chemistry (safety)

    Time frame: 24 months

  3. Adverse events (safety)

    Time frame: 24 months

Secondary outcomes

  1. Occurrence of antibodies to factor IX

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Prothya Biosolutions

Industry

Registry information

Official study title

Post Marketing Study in Haemophilia B Patients Using Nonafact® 100 IU/ml Powder and Solvent for Solution for Injection(Human Coagulation Factor IX)(Human Plasma Derived Factor IX Product, Freeze Dried)

Important dates

Study start
2003
Study completion
2007
First posted
Aug 31, 2005
Registry last updated
Aug 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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