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

NCT ID: NCT00139828

Last Updated: 2007-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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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'

Conditions

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Hemophilia B

Keywords

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haemophilia B factor IX Product Surveillance, Postmarketing plasma products

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

human coagulation Factor IX

Intervention Type DRUG

Interventions

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human coagulation Factor IX

Intervention Type DRUG

Other Intervention Names

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Nonafact

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prothya Biosolutions

INDUSTRY

Sponsor Role lead

Principal Investigators

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E P Mauser-Bunschoten, MD, PdD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands

Locations

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Academic Medical Centre

Amsterdam, , Netherlands

Site Status

Kennemer Gasthuis

Haarlem, , Netherlands

Site Status

LUMC

Leiden, , Netherlands

Site Status

UMC St. Radboud

Nijmegen, , Netherlands

Site Status

Erasmus Medical Centre

Rotterdam, , Netherlands

Site Status

Leyenburg Hospital

The Hague, , Netherlands

Site Status

Van Creveldkliniek

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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KB2000.03

Identifier Type: -

Identifier Source: org_study_id