NCT00978380|CompletedPhase 3Results

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

mentor™2

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

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

F13CD-37202008-007883-41U1111-1111-9289JapicCTI-121958

Study Type

interventional

Target

Locations

12 countries

Sites

Timeline

RegisteredSep 2009

StartedSep 2009

CompletionOct 2015

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Sep 2009

Longer than P75 for phase_3

Geographic Reach

12 countries

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.1 years study duration

First Submitted

Initial submission to the registry

September 15, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed

5 days until next milestone

Study Start

First participant enrolled

September 21, 2009

Completed

6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2015

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

December 13, 2016

Completed

Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

6.1 years

First QC Date

September 15, 2009

Results QC Date

October 19, 2016

Last Update Submit

January 18, 2018

Conditions

Congenital Bleeding Disorder Congenital FXIII Deficiency

Outcome Measures

Primary Outcomes (1)

Adverse Events (AEs)(Serious and Non-serious)
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.
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 Outcomes (1)

Antibody and Inhibitor Development
From week 0 to week 52

Study Arms (1)

A

EXPERIMENTAL

Drug: catridecacog

Interventions

catridecacogDRUG

Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)

Also known as: recombinant factor XIII

Eligibility Criteria

Age6 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.