Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 (mentor™2)
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ClinicalTrials.gov Identifier: NCT00978380 |
Recruitment Status
:
Completed
First Posted
: September 16, 2009
Results First Posted
: December 13, 2016
Last Update Posted
: January 24, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congenital Bleeding Disorder Congenital FXIII Deficiency | Drug: catridecacog | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official 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 |
Actual Study Start Date : | September 21, 2009 |
Actual Primary Completion Date : | October 20, 2015 |
Actual Study Completion Date : | October 20, 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: catridecacog
Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)
Other Name: recombinant factor XIII
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- 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. ]An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Trial AEs (serious) included any event such as death, life-threatening experience, in-subject hospitalisation, significant disability/ congential anomaly experienced from the trial product.
- Antibody and Inhibitor Development [ Time Frame: From week 0 to week 52 ]All subjects who received rFXIII were monitored for anti-rFXIII antibodies and inhibitor development. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors. Percentage of subjects with antibody and inhibitor development were reported.

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978380

Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Publications of Results:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00978380 History of Changes |
Other Study ID Numbers: |
F13CD-3720 2008-007883-41 ( EudraCT Number ) U1111-1111-9289 ( Other Identifier: WHO ) JapicCTI-121958 ( Registry Identifier: JAPIC ) |
First Posted: | September 16, 2009 Key Record Dates |
Results First Posted: | December 13, 2016 |
Last Update Posted: | January 24, 2018 |
Last Verified: | January 2018 |
Additional relevant MeSH terms:
Blood Coagulation Disorders Hemostatic Disorders Factor XIII Deficiency Hematologic Diseases Vascular Diseases |
Cardiovascular Diseases Hemorrhagic Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Genetic Diseases, Inborn |