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

August 29, 2007 updated by: Prothya Biosolutions

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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'

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Centre
      • Haarlem, Netherlands
        • Kennemer Gasthuis
      • Leiden, Netherlands, 2333 ZA
        • LUMC
      • Nijmegen, Netherlands, 6525 GA
        • UMC St. Radboud
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medical Centre
      • The Hague, Netherlands, 2545 CH
        • Leyenburg Hospital
      • Utrecht, Netherlands, 3584CX
        • Van Creveldkliniek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
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
Other Names:
  • Nonafact

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of bleeding episodes (efficacy after administration)
Time Frame: 24 months
24 months
Haematological variables and clinical chemistry (safety)
Time Frame: 24 months
24 months
Adverse events (safety)
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of antibodies to factor IX
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prothya Biosolutions

Investigators

  • Principal Investigator: E P Mauser-Bunschoten, MD, PdD, UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

August 30, 2007

Last Update Submitted That Met QC Criteria

August 29, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB2000.03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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