Hemophilia APhase 4NCT00765726
Study Evaluating The Safety Of Xyntha In Usual Care Settings
A Phase 4 study testing Moroctocog alfa(AF-CC) and Blood draw for laboratory testing in people with Hemophilia A, run by Pfizer at 6 sites in 2 countries.
Trial summary
The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. 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?
- Moroctocog alfa(AF-CC) and Blood draw for laboratory testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Feb 2009to Aug 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 patients 12 years of age and older.
- Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII replacement products.
- Treatment history of 150 or greater exposure days to any FVIII products prior to Enrollment visit.
- Negative inhibitor at screening or documentation of negative inhibitor titer within 6 weeks or less prior to study entry except for patients entering the study on immune tolerance induction therapy.
Who cannot join
- Bleeding disorder other than hemophilia A.
- Inhibitor titer greater than or equal to 0.6 BU during screening except for patients on immune tolerance induction therapy.
- Immunomodulatory therapy during screening period.
- Known hypersensitivity to hamster protein.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Pfizer Investigational Site
Dayton, Ohio, 45404-1815
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
East Lansing, Michigan, 48823
Pfizer Investigational Site
Los Angeles, California, 90007
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
New Zealand1 site
Pfizer Investigational Site
Christchurch, New Zealand, 8001
About this study
Official title: A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings
The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. Procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. Patients will be required to complete an infusion log for each Xyntha infusion.
Read the detailed description
The study was terminated on May 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with ReFacto AF.
The termination of this study has no impact on subject safety or well being. The decision to terminate the trial was not based on any safety concerns.
- Conditions
- Hemophilia A
- Being tested
- Moroctocog alfa(AF-CC), Blood draw for laboratory testing
- Keywords
- hemophilia, hemophilia A, ReFacto, Xyntha, moroctocog alfa, bleeding disorder
- Medical subject headings
- Hemophilia A, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moroctocog alfa(AF-CC)Biological
Also called Xyntha
Dosing is at the discretion of the investigator during the study
Blood draw for laboratory testingProcedure or surgery
Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies
| Study group | Role | What they receive |
|---|---|---|
| Moroctocog alfa(AF-CC) | Other | Not described Receives: Biological: Moroctocog alfa(AF-CC); Procedure: Blood draw for laboratory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Factor VIII (FVIII) Inhibitor Development
FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.
Measured: Month 24 or early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionAug 2011
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765726
- Sponsor's protocol ID
- 3082B2-4418
- Other IDs
- B1831003
- Status last verified
- Dec 2011
- First submitted
- 2 Oct 2008
- Last updated
- 20 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings
- ClinicalTrials.gov ID
- NCT00765726
- Acronym / sponsor ID
- 3082B2-4418
- Conditions
- Hemophilia A
- Keywords
- hemophilia, hemophilia A, ReFacto, Xyntha, moroctocog alfa, bleeding disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Posted 20 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. Procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. Patients will be required to complete an infusion log for each Xyntha infusion.
Detailed description
The study was terminated on May 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with ReFacto AF.
The termination of this study has no impact on subject safety or well being. The decision to terminate the trial was not based on any safety concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moroctocog alfa(AF-CC) | Other | Biological: Moroctocog alfa(AF-CC), Procedure: Blood draw for laboratory testing |
Who may qualify
- Ages
- 12 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients 12 years of age and older.
- Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII replacement products.
- Treatment history of 150 or greater exposure days to any FVIII products prior to Enrollment visit.
- Negative inhibitor at screening or documentation of negative inhibitor titer within 6 weeks or less prior to study entry except for patients entering the study on immune tolerance induction therapy.
Key exclusion criteria (4 listed)
- Bleeding disorder other than hemophilia A.
- Inhibitor titer greater than or equal to 0.6 BU during screening except for patients on immune tolerance induction therapy.
- Immunomodulatory therapy during screening period.
- 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 |
|---|---|---|
| Moroctocog alfa(AF-CC)Also: XynthaDosing is at the discretion of the investigator during the study | Biological | Moroctocog alfa(AF-CC) |
| Blood draw for laboratory testingHematology and Chemistry panels, Factor VIII inhibitor and recovery studies | Procedure or surgery | Moroctocog alfa(AF-CC) |
Primary outcome
Percentage of Participants With Factor VIII (FVIII) Inhibitor Development
Time frame: Month 24 or early withdrawal
FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
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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.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moroctocog alfa(AF-CC) and Blood draw for laboratory testing in people with Hemophilia A, run by Pfizer at 6 sites in 2 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, New Zealand. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Factor VIII (FVIII) Inhibitor Development (time frame: Month 24 or early withdrawal). 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 20 Jan 2012.