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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023803-92 | EudraCT Number | ||
| U1111-1118-2228 | Other Identifier | WHO | |
| JapicCTI-111595 | Registry Identifier | JAPIC |
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This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.
Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rFVIIa | Experimental |
| |
| vatreptocog alfa | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vatreptacog alfa (activated) | Drug | 1-3 doses per bleeding episode |
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| Measure | Description | Time Frame |
|---|---|---|
| Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given | Within 12 hours of first trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Effective and Sustained Bleeding Control | Up to 48 hours after first trial product administration | |
| Number of Doses of Trial Product Given for Each Acute Bleed | Up to 6 hours after first trial product administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Clinical Trial Call Center | Tucson | Arizona | 85724-0001 | United States | ||
| Novo Nordisk Clinical Trial Call Center |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Patients treated with vatreptacog alfa were recruited from a total of 46 sites globally in 18 countries, including Austria, Brazil, Croatia, Greece, Hungary, Italy, Japan, Malaysia, Poland, Romania, Russia, Serbia, South Africa, Taiwan, Thailand, Turkey, United Kingdom and United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vatreptacog Alfa and rFVIIa (All Subjects) | Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner. Subjects participating in the trial had bleeding episodes randomised to treatment with either vatraptacog alfa or rFVIIa in an independent manner for each bleeding episodes. Of the 72 subjects, 3 subjects did not have any bleeds. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| eptacog alfa (activated) |
| Drug |
1-3 doses per bleeding episode |
|
| Number of Adverse Events | Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product. |
| Immunogenicity (Inhibitor Development) | Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or FVII. Radioimmunoassay using [125I]-labelled vatreptacog alfa or rFVIIa was used to screen plasma samples for development of anti-drug antibodies | Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product. |
| Los Angeles |
| California |
| 90007 |
| United States |
| Novo Nordisk Clinical Trial Call Center | Los Angeles | California | 90027 | United States |
| Novo Nordisk Clinical Trial Call Center | Orange | California | 92868 | United States |
| Novo Nordisk Clinical Trial Call Center | Aurora | Colorado | 80045 | United States |
| Novo Nordisk Clinical Trial Call Center | Tampa | Florida | 33607 | United States |
| Novo Nordisk Clinical Trial Call Center | Atlanta | Georgia | 30322 | United States |
| Novo Nordisk Clinical Trial Call Center | Augusta | Georgia | 30912 | United States |
| Novo Nordisk Clinical Trial Call Center | Iowa City | Iowa | 52242 | United States |
| Novo Nordisk Clinical Trial Call Center | Boston | Massachusetts | 02115 | United States |
| Novo Nordisk Clinical Trial Call Center | Detroit | Michigan | 48202-2608 | United States |
| Novo Nordisk Clinical Trial Call Center | Brooklyn | New York | 11219 | United States |
| Novo Nordisk Clinical Trial Call Center | Portland | Oregon | 97239 | United States |
| Novo Nordisk Clinical Trial Call Center | Richmond | Virginia | 23219 | United States |
| Linz | A 4020 | Austria |
| Campinas | São Paulo | 13081970 | Brazil |
| Zagreb | 10 000 | Croatia |
| Athens | GR-11527 | Greece |
| Budapest | H-1134 | Hungary |
| Milan | 20124 | Italy |
| Shinjuku-ku, Tokyo | 160 0023 | Japan |
| Kuala Lumpur | 50400 | Malaysia |
| Warsaw | 02-776 | Poland |
| Novo Nordisk Clinical Trial Call Center | San Juan | 00935 | Puerto Rico |
| Timișoara | Timiș County | 300011 | Romania |
| Saint Petersburg | 191186 | Russia |
| Novi Sad | 21000 | Serbia |
| Parktown, Johannesburg | Gauteng | 2193 | South Africa |
| Changhua | 500 | Taiwan |
| Bangkok | 10400 | Thailand |
| Bornova-IZMIR | 35100 | Turkey (Türkiye) |
| Oxford | OX3 7LJ | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vatrepcacog Alfa and rFVIIa | Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given | Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number. | Posted | Number | bleeding episodes | Within 12 hours of first trial product administration |
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| Secondary | Effective and Sustained Bleeding Control | Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number. | Posted | Number | bleeding episodes | Up to 48 hours after first trial product administration |
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| Secondary | Number of Doses of Trial Product Given for Each Acute Bleed | Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number. | Posted | Number | bleeding episodes | Up to 6 hours after first trial product administration |
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| Secondary | Number of Adverse Events | Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All patients exposed to at least one dose of trial product was included in the safety analysis set. Patients received scheduled doses with rFVIIa, and treatment (rVIIa and vatreptacog alfa) for each bleeding episode. | Posted | Number | events | Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product. |
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| Secondary | Immunogenicity (Inhibitor Development) | Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or FVII. Radioimmunoassay using [125I]-labelled vatreptacog alfa or rFVIIa was used to screen plasma samples for development of anti-drug antibodies | All patients exposed to at least one dose of trial product was included in the safety analysis set. Patients received scheduled doses with rFVIIa, and treatment (rVIIa and vatreptacog alfa) for each bleeding episode. | Posted | Number | Subjects | Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product. |
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Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.
All patients exposed to at least one dose of trial product was included in the safety analysis set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vatreptacog Alfa 80 µg/kg | Vatreptacog alfa was administered intravenous bolus, 1-3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed | 4 | 72 | 5 | 72 | ||
| EG001 | rFVIIa 90 µg/kg | Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1-3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed | 4 | 57 | 3 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Rectal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug specific antibody present | Investigations | MedDRA 16.0 | Systematic Assessment |
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Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Novo Nordisk reserves the right to prior review of such publications and to ask for delay of publication of individual site results until after the primary manuscript is accepted for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| C000596433 | vatreptacog alfa |
| D005167 | Factor VII |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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