CompletedPhase 3

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

United States63 participantsStarted 2009-09-21

Plain-language summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.

Who can participate

Age range6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Adverse Events (AEs)(Serious and Non-serious)

Timeframe: All AEs were collected and reported from screening (week 0) for a minimum period of 52 weeks or until the end of trial visit.

Trial details

NCT IDNCT00978380

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10-20

Results submitted2016-10-19