Study Evaluating The Safety Of Xyntha In Usual Care Settings
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00765726
First received: October 2, 2008
Last updated: December 16, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemophilia A |
Biological: Moroctocog alfa(AF-CC) Procedure: Blood draw for laboratory testing |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings |
Resource links provided by NLM:
Genetics Home Reference related topics:
hemophilia
MedlinePlus related topics:
Hemophilia
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Participants With Factor VIII (FVIII) Inhibitor Development [ Time Frame: Month 24 or early withdrawal ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 12 |
| Study Start Date: | February 2009 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Moroctocog alfa(AF-CC) |
Biological: Moroctocog alfa(AF-CC)
Dosing is at the discretion of the investigator during the study
Other Name: Xyntha
Procedure: Blood draw for laboratory testing
Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies
|
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765726
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90007 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| Pfizer Investigational Site | |
| East Lansing, Michigan, United States, 48823 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45404-1815 | |
| New Zealand | |
| Pfizer Investigational Site | |
| Christchurch, New Zealand, 8001 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00765726 History of Changes |
| Other Study ID Numbers: | 3082B2-4418, B1831003 |
| Study First Received: | October 2, 2008 |
| Results First Received: | December 16, 2011 |
| Last Updated: | December 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
hemophilia hemophilia A ReFacto |
Xyntha moroctocog alfa bleeding disorder |
Additional relevant MeSH terms:
|
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders Hemorrhagic Disorders |
Genetic Diseases, Inborn Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013