Safety Study of Recombinant Factor XIII (rFXIII) in Patients With Congenital Factor XIII Deficiency - Tabular View

Tracking Information
First Received Date ^ICMJE	March 18, 2003
Last Updated Date	March 6, 2009
Start Date ^ICMJE	February 2003
Primary Completion Date	October 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00056589 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety Study of Recombinant Factor XIII (rFXIII) in Patients With Congenital Factor XIII Deficiency
Official Title ^ICMJE	A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency
Brief Summary	The purpose of this study is to determine the safety of increasing doses of rFXIII in subjects with Congenital Factor XIII Deficiency.
Detailed Description	This is a Phase 1, single-site, open-label study to evaluate the safety and pharmacokinetics of escalating doses of rFXIII in subjects with Congenital Factor XIII Deficiency.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study
Condition ^ICMJE	Congenital Factor XIII Deficiency
Intervention ^ICMJE	Drug: Recombinant factor XIII
Study Arms / Comparison Groups
Publications *	Lovejoy AE, Reynolds TC, Visich JE, Butine MD, Young G, Belvedere MA, Blain RC, Pederson SM, Ishak LM, Nugent DJ. Safety and pharmacokinetics of recombinant factor XIII-A2 administration in patients with congenital factor XIII deficiency. Blood. 2006 Jul 1;108(1):57-62. Epub 2006 Mar 23.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	October 2003
Primary Completion Date	October 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria Subject is at least 18 years of age at the time of enrollment. Subject has documented congenital FXIII deficiency. Subject has normal platelet count and clotting parameters defined as platelet count, PT, PTT, INR, thrombin time and fibrinogen within 2.5% of normal limits. Subject has adequate renal and hepatic function defined as: creatinine is less or equal to 2.0 mg%, bilirubin is less or equal 1.5 times upper limit of normal; alkaline phosphatase is less or equal to 3 times upper limit of normal and AST is less or equal to 3 times upper limit of normal. If female and of child-bearing potential, subject has a negative serum pregnancy test within seven (7) days of enrollment. If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits. Subject has a negative drug and alcohol screen. Subject agrees to abstain from alcohol intake for 24 hours prior to admittance to the test facility and during the confinement period. Patient has signed an IRB-approved informed consent form. Exclusion Criteria Subject has received blood products or FXIII concentrates within four weeks of study enrollment. Subject has known antibodies to FXIII. Subject has a hereditary or acquired coagulation disorder other than FXIII deficiency. Subject has a previous history of autoimmune disorder involving autoantibodies, e.g., systemic lupus erythematosus. Subject has a previous history of thromboembolic events, e.g., cerebrovascular accident or deep vein thrombosis or who has received any antithrombotic or anti-platelet drugs within 7 days of study enrollment. Subject has received treatment with any experimental agent within 30 days of study enrollment. Subject is pregnant or lactating. Subject has any concurrent serious chronic or acute illness or infection. Subject has had any surgical procedure in the 30 days prior to enrollment. Subject has donated blood within 30 days prior to enrollment. Subject has medical, social or psychosocial factors expected to impact compliance or safety.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00056589
Responsible Party
Study ID Numbers ^ICMJE	CD1
Study Sponsor ^ICMJE	ZymoGenetics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	ZymoGenetics
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP