ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	27 July 2020
Main ID:	EUCTR2004-002648-88-GB
Date of registration:	19/04/2005
Prospective Registration:	Yes
Primary sponsor:	Wyeth Pharmaceuticals
Public title:	In vitro evaluation of allergic reactions in hemophilia B subjects who have exhibited a systemic allergic response after exposure to BeneFIX (Nonacog Alfa; recombinant Factor IX) - Basophil Clinical Study
Scientific title:	In vitro evaluation of allergic reactions in hemophilia B subjects who have exhibited a systemic allergic response after exposure to BeneFIX (Nonacog Alfa; recombinant Factor IX) - Basophil Clinical Study
Date of first enrolment:	17/11/2005
Target sample size:	18
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002648-88
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Control group If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
France	Germany	United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Study Group:
1. Written informed consent or assent, as applicable.
2. Subjects with moderate to severe hemophilia B (FIX: C <5%), who have reported class II (systemic with respiratory involvement) or class III (severe anaphylaxis with hypotension) allergic manifestations within 24 hours of a BeneFIX infusion.
Control Group:
1. Written informed consent or assent, as applicable.
2. Subjects with moderate to severe hemophilia B (FIX: c <5%).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Study Group:
1. Subjects who had NO reaction when rechallenged with BeneFIX, in the absence of prophylactic immunomodulating therapy.
2. Subjects whose most recent allergic manifestations with BeneFIX occurred > 36 months prior to providing written consent for this study.
3. Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled visit for this study.
4. Subjects with immune disorders (e.g. HIV, myeloma, lymphoma).
5. Subjects unable to comply with a minimum 5-day FIX washout requirement.
Control Group:
1. Subjects with documented evidence of prior class II or class III allergic reaction to any FIX product.
2. Subjects with documeted evidence of prior or current FIX inhibitor (BU > or = to 0.6).
3. Subjects who have taken antihistimine, steroidal, or other immunosuppresive therapy within 72 hours of the scheduled study visit.
4. Subjects with immune disorder (e.g. HIV, myeloma, lymphoma).
5. Subjects unable to comply with a minimum 5-day FIX washout requirement.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Hemophilia B

Intervention(s)

Trade Name: BeneFIX
Product Name: BeneFIX
Product Code: 3090
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Nonacog alfa
Current Sponsor code: 3090
Other descriptive name: Recombinant Coagulation Factor IX
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 250-1000

Primary Outcome(s)

Primary end point(s): Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups.

Main Objective: Primary: Describe the histamine release patterns produced by activated basophils obtained from peripheral blood of subjects who meet the protocol entry criteria, using the methodology described in the protocol.

Secondary Objective: N/A

Secondary Outcome(s)

Secondary ID(s)

3090A-101795

N/A

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 17/11/2005
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.