Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Congenital FXIII Deficiency; Congenital Bleeding Disorder

Treatments: Drug: catridecacog

Study type: Interventional

Funder types: Industry

Identifiers

NCT00056589

F13-1663

Details and patient eligibility

About

This trial was conducted in the United States of America (USA). The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documental congenital FXIII deficiency
• Normal platelet count and clotting parameters
• Adequate renal and hepatic function
• If female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment
• If a sexually active male or a sexually active female of child-bearing potential, agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
• Negative drug and alcohol screens

Exclusion criteria

• Received blood products or FXIII concentrates within 4 weeks of study enrollment
• Known antibodies to FXIII
• Hereditary or acquired coagulation disorder other than FXIII deficiency
• Previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus
• Previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment
• Received treatment with any experimental agent within 30 days of study enrollment
• Any surgical procedure in the 30 days prior to enrollment
• Donated blood within 30 days prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

rFXIII

Experimental group

Treatment:

Drug: catridecacog