Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00978380
• Date of registration: 15/09/2009
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 mentor™2
• Scientific title: A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency
• Date of first enrolment: September 21, 2009
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00978380
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Canada, Finland, France, Germany, Israel, Italy, Japan, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- For subjects who participated in F13CD-1725:

- Previous participation (means up to and inclusive Visit 16, (End of Trial)) in
F13CD-1725

- For all other subjects:

- Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at
screening visit or documented results from previously performed genotyping)

- Body weight at least 20 kg

Exclusion Criteria:

- Known neutralizing antibodies (inhibitors) towards FXIII

- Any known congenital or acquired coagulation disorder other than congenital FXIII
deficiency

- Platelet count (thrombocytes) of less than 50 × 109/L. For subjects who participated
in F13CD-1725 platelet count from visit 15 in F13CD-1725 must be used for evaluation.

- Females of childbearing potential who are pregnant, breastfeeding or are not using
adequate contraceptive methods



Age minimum: 6 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Congenital Bleeding Disorder

Congenital FXIII Deficiency

Intervention(s)

Drug: catridecacog

Primary Outcome(s)

Adverse Events (AEs)(Serious and Non-serious) [Time Frame: All AEs were collected and reported from screening (week 0) for a minimum period of 52 weeks or until the end of trial visit.]

Secondary Outcome(s)

Antibody and Inhibitor Development [Time Frame: From week 0 to week 52]

Secondary ID(s)

JapicCTI-121958

U1111-1111-9289

2008-007883-41

F13CD-3720

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/12/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00978380