A Phase 3 interventional study of catridecacog in Congenital Bleeding Disorder and Congenital FXIII Deficiency, sponsored by Novo Nordisk A/S. Completed at 35 sites in 11 countries. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2017-02-24.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Prevention
The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 41 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
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Exclusion Criteria:
Drug: catridecacog
35 IU/kg body weight, i.v. administration, once every 4 weeks
Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period
It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product.
Time frame: For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).
Percentage of Subjects Having a Normal Clot Solubility One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits
Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).
Time frame: For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).
Level of FXIII Activity One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits
Subjects entered a 52-week treatment period of monthly (28±2 days) doses of 35 IU/kg rFXIII. Blood samples for analysis of FXIII activity were drawn at each visit; at dosing visits blood was drawn 1 hour after administration and before administration(corresponding to 28 days after the previous dose). All Dosing Visits are visits where a dose is given (i.e. Visit 2-15 except Visit 3).
Time frame: For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).
Number of Subjects With rFXIII Antibody Development
Subjects receiving rFXIII were monitored for the development of binding antibodies. Blood sampling was done before administration of trial product at all visits (Visits 1-16 and unscheduled visit)
Time frame: For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).
Of a total of 29 initiated trial sites, 23 sites enrolled and dosed at least one patient. The country distribution was (number of actively recruiting sites per country in parenthesis): Austria (1), Canada (1), Finland (1), France (1), Germany (3), Israel (2), Italy (1), Spain (1), Switzerland (1), UK (3) and United States of America (8)
| Milestone | rFXIII |
|---|---|
| Started | 41 |
| Completed | 33 |
| Not completed | 8 |
| Withdrew: Adverse event | 1 |
| Withdrew: Unclassified | 2 |
| Withdrew: According to protocol | 2 |
| Withdrew: Development of antibodies | 3 |
It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product.
| bleeding episodes per subject per year | rFXIII |
|---|---|
| Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period | 0.138 (0 to 2) |
Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).
| percentage (%) of subjects | rFXIII |
|---|---|
| After 1 hour post-dosing (N=444) | 98.2 |
| After 28 days of treatment (N=419) | 91.3 |
Subjects entered a 52-week treatment period of monthly (28±2 days) doses of 35 IU/kg rFXIII. Blood samples for analysis of FXIII activity were drawn at each visit; at dosing visits blood was drawn 1 hour after administration and before administration(corresponding to 28 days after the previous dose). All Dosing Visits are visits where a dose is given (i.e. Visit 2-15 except Visit 3).
| U/kg | rFXIII |
|---|---|
| After 1 hour post-dosing (N=453) | 0.782 ± 0.342 |
| After 28 days of treatment (N=459) | 0.189 ± 0.102 |
Subjects receiving rFXIII were monitored for the development of binding antibodies. Blood sampling was done before administration of trial product at all visits (Visits 1-16 and unscheduled visit)
| participants | rFXIII |
|---|---|
| Number of Subjects With rFXIII Antibody Development | 4 |
Collected over Adverse events (AEs) were collected and reported during the entire study period i.e. approximately one year (322 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rFXIII | — | 6/41 (14.6%) | 25/41 (61%) |
| Event | rFXIII |
|---|---|
| Antibody test positiveInvestigations | 3/41 |
| Small intestinal obstructionGastrointestinal disorders | 1/41 |
| Non-cardiac chest painGeneral disorders | 1/41 |
| DiverticulitisInfections and infestations | 1/41 |
| Road traffic accidentInjury, poisoning and procedural complications | 1/41 |
| HeadacheNervous system disorders | 1/41 |
| Event | rFXIII |
|---|---|
| HeadacheNervous system disorders | 11/41 |
| NasopharyngitisInfections and infestations | 8/41 |
| PyrexiaGeneral disorders | 7/41 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/41 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 5/41 |
| InfluenzaInfections and infestations | 4/41 |
| Incorrect dose administeredInjury, poisoning and procedural complications | 4/41 |
| Pain In ExtremityMusculoskeletal and connective tissue disorders | 4/41 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 4/41 |
| DiarrhoeaGastrointestinal disorders | 3/41 |
| Age, Continuous(years) | rFXIII |
|---|---|
| Mean | 26.4 ± 15.9 |
| Gender(Participants) | rFXIII |
|---|---|
| Female | 18 |
| Male | 23 |
| Race/Ethnicity, Customized(participants) | rFXIII |
|---|---|
| Black or African American | 2 |
| White | 28 |
| Asian | 5 |
| Other | 5 |
| Unknown | 1 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S