Hemophilia APhase 4NCT00092976
Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
A Phase 4 study testing ReFacto in people with Hemophilia A, run by Wyeth is now a wholly owned subsidiary of Pfizer at 4 sites in United States.
Trial summary
The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory. Read more about this study
- Who is it for?
- Ages 6 years and older, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- ReFacto
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2003to Jul 2007
- Phase
- Phase 4
- 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 6 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 6 years
- Male previously treated patients (≥150 Exposure Days) with moderate or severe hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis)
- Ability to adhere to the protocol requirements
Who cannot join
- Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as > 0.6 BU
- Prior participation in this study
- Any concomitant bleeding disorder other than hemophilia A
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Cincinnati, Ohio, 45229
Study site
Hershey, Pennsylvania, 17033
Study site
Los Angeles, California, 90007
Study site
New Brunswick, New Jersey, 08903-0019
About this study
Official title: A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia A Undergoing Major Surgery Monitored Using the Chromogenic Substrate Assay at the Local Laboratory
The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.
- Conditions
- Hemophilia A
- Being tested
- ReFacto
- 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.
ReFactoDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.
Secondary outcomes (1)
To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2004 (estimated)
- Study startFeb 2003
- Study completionJul 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, MD, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00092976
- Sponsor's protocol ID
- 3082A2-401
- Status last verified
- May 2006
- First submitted
- 28 Sep 2004
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia A Undergoing Major Surgery Monitored Using the Chromogenic Substrate Assay at the Local Laboratory
- ClinicalTrials.gov ID
- NCT00092976
- Acronym / sponsor ID
- 3082A2-401
- Conditions
- Hemophilia A
- Keywords
- Hemophilia A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Sep 2004 (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 primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 6 years
- Male previously treated patients (≥150 Exposure Days) with moderate or severe hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis)
- Ability to adhere to the protocol requirements
Key exclusion criteria (3 listed)
- Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as > 0.6 BU
- Prior participation in this study
- Any concomitant bleeding disorder other than hemophilia A
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 | Drug | – |
Primary outcome
To evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.
1 secondary outcome
To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory
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 28 Dec 2007.
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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, MD study director
Wyeth is now a wholly owned subsidiary of Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ReFacto in people with Hemophilia A, run by Wyeth is now a wholly owned subsidiary of Pfizer at 4 sites in United States.
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 28 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 4 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.. 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 28 Dec 2007.