Hemophilia BNCT00195221
Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B
An observational study of Hemophilia B and Allergic Reactions, run by Wyeth is now a wholly owned subsidiary of Pfizer at 38 sites in 9 countries.
Trial summary
Retrospective, multicenter study in patients with hemophilia B. This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU, and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia B, Allergic Reactions
- How many people
- 166 participants
- Where
- 38 sitesin 9 countries
- Study dates
- Feb 2005to Nov 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written consent to release patient information
- Living or deceased patients with mild to severe hemophilia B who have had at least 1 exposure to replacement factor IX product(s).
- Living or deceased patients who had their first infusion of any FIX product between 1 January 1991 and 31 December 2003.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
38 sites in 9 countries.
38 sites in 9 countries
United States15 sites
Study site
Atlanta, Georgia, 30322
Study site
Boise, Idaho, 83712
Study site
Dayton, Ohio, 45404-1815
Study site
East Lansing, Michigan, 48823
Study site
Fort Worth, Texas, 76104
Study site
Iowa City, Iowa, 52242
Study site
Memphis, Tennessee, 38105
Study site
New Brunswick, New Jersey, 08903
Study site
Orange, California, 92868
Study site
Peoria, Illinois, 61614
Study site
Philadelphia, Pennsylvania, 19104
Study site
Phoenix, Arizona, 85016
Study site
Rochester, Minnesota, 55905
Study site
San Antonio, Texas, 78207
Study site
Seattle, Washington, 98105
Italy9 sites
Study site
Catania, 95124
Study site
Catanzaro, 88100
Study site
Milan, 20162
Study site
Naples, 5-80131
Study site
Padova, 35128
Study site
Palermo, 90100
Study site
Parma, 43100
Study site
Perugia, 06100
Study site
Vicenza, 36100
France4 sites
Study site
Liffré, 35340
Study site
Montmorency, 95160
Study site
Paris, 75014
Study site
Strasbourg, 67098
United Kingdom2 sites
Study site
Cardiff, CF14 4XN
Study site
Wolverhampton, Wstmid, WV10 0QP
About this study
Official title: A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B
Retrospective, multicenter study in patients with hemophilia B. This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU, and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate.
Following informed consent and eligibility, historical patient information including demographics, allergy history, hemophilia history, frequency and severity of allergic reaction(s), number of exposure days with products causing allergic reactions, exposure days to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of event(s), any other adverse event(s) occuring within 48 hours of onset of allergic reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and outcome, current status of patient, and results of any special studies (eg, skin or RAST testing, alloantibody analyses, ect) will be collected.
- Conditions
- Hemophilia B, Allergic Reactions
- Keywords
- Hemophilia B
- Medical subject headings
- Hemophilia B, Hypersensitivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 166 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Germany, MedInfoDEU@wyeth.comTrial Manager, Principal investigator, For Austria, WPVIMED@wyeth.comTrial Manager, Principal investigator, For UK, ukmedinfo@wyeth.comTrial Manager, Principal investigator, For Italy, decresg@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195221
- Sponsor's protocol ID
- 3090A-101657
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 5 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B
- ClinicalTrials.gov ID
- NCT00195221
- Acronym / sponsor ID
- 3090A-101657
- Conditions
- Hemophilia B, Allergic Reactions
- Keywords
- Hemophilia B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective, multicenter study in patients with hemophilia B. This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU, and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate.
Following informed consent and eligibility, historical patient information including demographics, allergy history, hemophilia history, frequency and severity of allergic reaction(s), number of exposure days with products causing allergic reactions, exposure days to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of event(s), any other adverse event(s) occuring within 48 hours of onset of allergic reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and outcome, current status of patient, and results of any special studies (eg, skin or RAST testing, alloantibody analyses, ect) will be collected.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Written consent to release patient information
- Living or deceased patients with mild to severe hemophilia B who have had at least 1 exposure to replacement factor IX product(s).
- Living or deceased patients who had their first infusion of any FIX product between 1 January 1991 and 31 December 2003.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2007.
Related trials for Hemophilia B
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruitingPhase 1
Lentiviral FIX Gene Therapy
Hemophilia B
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For Germany, MedInfoDEU@wyeth.com
Trial Manager principal investigator
For Austria, WPVIMED@wyeth.com
38 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia B and Allergic Reactions, run by Wyeth is now a wholly owned subsidiary of Pfizer at 38 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Italy, France, Belgium, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2007.