Post Marketing Study in Haemophilia B Patients Using Nona... | NCT00139828

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

NCT00139828

Sponsor

Prothya Biosolutions

Status

Completed

Last Update Posted

Aug 30, 2007Estimated

Enrollment

12Actual

Phase

Phase 4

Conditions

Hemophilia B

Interventions

human coagulation Factor IX

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Aug 30, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Aug 31, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2007

Last Update Posted Date

Aug 30, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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'

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
human coagulation Factor IX	Drug		A	Nonafact

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of antibodies to factor IX		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
E P Mauser-Bunschoten, MD, PdD	UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Medical Centre		Amsterdam		1105 AZ	Netherlands
Kennemer Gasthuis

Condition Browse Module

MeSH Terms

ID	Term
D002836	Hemophilia B

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005164	Factor IX

Ancestor Terms

ID	Term
D004792	Enzyme Precursors
D045762	Enzymes and Coenzymes
D001779	Blood Coagulation Factors
D001798	Blood Proteins

Browse Leaves

Not provided

Browse Branches

Not provided