Hemophilia APhase 3NCT00141843
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
A Phase 3 study testing ReFacto AF, B-Domain deleted Recombinant Factor VIII and BDDrFVIII in people with Hemophilia A, run by Wyeth is now a wholly owned subsidiary of Pfizer at 41 sites in 13 countries.
Trial summary
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A. Read more about this study
- Who is it for?
- Ages 12 years and older, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- ReFacto AF, B-Domain deleted Recombinant Factor VIII and BDDrFVIII
- How many people
- 100 participants
- Where
- 41 sitesin 13 countries
- Study dates
- Jul 2005to Nov 2006
- Phase
- Phase 3
- 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 12 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male subjects with severe or moderately severe hemophilia A
- A negative past medical history of a Factor VIII inhibitor
- Age greater than or equal to 12 years
Who cannot join
- A history of Factor VIII inhibitors
- Presence of a bleeding disorder in addition to hemophilia
- Known hypersensitivity to hamster protein
Trial locations and contacts
41 sites in 13 countries.
41 sites in 13 countries
United States21 sites
Study site
Atlanta, Georgia, 30322
Study site
Aurora, Colorado, 80045
Study site
Buffalo, New York, 14215
Study site
Chapel Hill, North Carolina, 27599
Study site
Charlottesville, Virginia, 22908
Study site
Dayton, Ohio, 45404
Study site
East Lansing, Michigan, 48823
Study site
Hershey, Pennsylvania, 17033
Study site
Houston, Texas, 77030
Study site
Iowa City, Iowa, 52242
Study site
Nashville, Tennessee, 37232
Study site
New Brunswick, New Jersey, 08903-0019
Study site
New Hyde Park, New York, 11040
Study site
New Orleans, Louisiana, 70112
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona, 85016
Study site
Sacramento, California, 95817
Study site
Salt Lake City, Utah, 84113
Study site
San Diego, California, 92123
Study site
St Louis, Missouri, 63014
Study site
Worcester, Massachusetts, 01605
Poland4 sites
Study site
Lodz, 95-510
Study site
Poznan
Study site
Warsaw, 00-576
Study site
Wroclaw
About this study
Official title: A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.
- Conditions
- Hemophilia A
- Being tested
- ReFacto AF, B-Domain deleted Recombinant Factor VIII, BDDrFVIII
- Keywords
- Hemophilia A
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReFacto AFGenetic
B-Domain deleted Recombinant Factor VIIIGenetic
BDDrFVIIIGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.
Secondary outcomes (1)
To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 100 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 Italy, descresg@wyeth.comTrial Manager, Principal investigator, For Australia, New Zealand, medinfo@wyeth.comTrial Manager, Principal investigator, For Netherlands, trials-NL@wyeth.comTrial Manager, Principal investigator, For Sweden, Finland,MedInfoNord@wyeth.comTrial Manager, Principal investigator, For Hungary, WPBUMED@wyeth.comTrial Manager, Principal investigator, For Poland, WVWZMED@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141843
- Sponsor's protocol ID
- 3082B2-310
- Status last verified
- Apr 2008
- First submitted
- 30 Aug 2005
- Last updated
- 22 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.
- ClinicalTrials.gov ID
- NCT00141843
- Acronym / sponsor ID
- 3082B2-310
- Conditions
- Hemophilia A
- Keywords
- Hemophilia A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 1 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.
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male subjects with severe or moderately severe hemophilia A
- A negative past medical history of a Factor VIII inhibitor
- Age greater than or equal to 12 years
Key exclusion criteria (3 listed)
- A history of Factor VIII inhibitors
- Presence of a bleeding disorder in addition to hemophilia
- Known hypersensitivity to hamster protein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReFacto AF | Genetic | – |
| B-Domain deleted Recombinant Factor VIII | Genetic | – |
| BDDrFVIII | Genetic | – |
Primary outcome
To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.
1 secondary outcome
To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time.
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 22 Apr 2008.
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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 Italy, descresg@wyeth.com
41 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ReFacto AF, B-Domain deleted Recombinant Factor VIII and BDDrFVIII in people with Hemophilia A, run by Wyeth is now a wholly owned subsidiary of Pfizer at 41 sites in 13 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 3 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 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Poland, France, Germany, New Zealand and 8 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.. It is what the study was designed to measure, not a finding.
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 22 Apr 2008.