Study Evaluating On-Demand Treatment With Xyntha in Chinese Subjects

This study is currently recruiting participants.

Verified by Wyeth, March 2009

First Received: March 19, 2009 Last Updated: March 23, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00868530

Purpose

This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.

Condition	Intervention	Phase
Hemophilia A	Biological: Xyntha	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Evaluation of the Safety and Efficacy of On-Demand Treatment With Xyntha (B Domain Deleted Recombinant Factor VIII, Albumin Free) in Chinese Subjects With Hemophilia A

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia

Drug Information available for: Octocog alfa Moroctocog Alfa Factor VIII

Further study details as provided by Wyeth:

Primary Outcome Measures:

the response of bleeding episodes to Xyntha treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

the number of infusions required to resolve bleeding episodes; the incidence of less than expected therapeutic effect (LETE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	February 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Xyntha: Experimental	Biological: Xyntha

Eligibility

Criteria

Inclusion Criteria:

Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A (FVIII activity: more than 5%, 1-5%, or less than 1%, respectively)
Subjects with previous exposure to FVIII replacement therapy
If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868530

Contacts

Contact: Trial Manager

Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3082B2-3316
Study First Received:	March 19, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00868530 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders

Hemophilia A
Hemostatic Disorders
Factor VIII

Additional relevant MeSH terms:

Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A

ClinicalTrials.gov processed this record on September 09, 2009