A Phase 3 interventional study of vatreptacog alfa (activated) and eptacog alfa (activated) in Congenital Bleeding Disorder, Haemophilia A With Inhibitors and Haemophilia B With Inhibitors, sponsored by Novo Nordisk A/S. Completed at 32 sites in 19 countries. Open to male participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
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.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 72 is above 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: eptacog alfa (activated)
Drug: vatreptacog alfa (activated)
1-3 doses per bleeding episode
1-3 doses per bleeding episode
Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given
Time frame: Within 12 hours of first trial product administration
Effective and Sustained Bleeding Control
Time frame: Up to 48 hours after first trial product administration
Number of Doses of Trial Product Given for Each Acute Bleed
Time frame: Up to 6 hours after first trial product administration
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.
Time frame: 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
Time frame: 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.
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.
| Milestone | Vatreptacog Alfa and rFVIIa (All Subjects) |
|---|---|
| Started | 72 |
| Completed | 64 |
| Not completed | 8 |
| Withdrew: Adverse event | 2 |
| Withdrew: Non-compliance | 2 |
| Withdrew: Withdrawal criteria | 3 |
| Withdrew: Unclassified | 1 |
| bleeding episodes | Vatreptacog Alfa 80 µg/kg | rFVIIa 90 µg/kg |
|---|---|---|
| Additional haemostatic given | 22 | 16 |
| Additional haemostatic not given | 318 | 211 |
| bleeding episodes | Vatreptacog Alfa 80 µg/kg | rFVIIa 90 µg/kg |
|---|---|---|
| Additional haemostatic given | 53 | 51 |
| Additional haemostatic not given | 268 | 163 |
| bleeding episodes | Vatreptacog Alfa 80 µg/kg | rFVIIa 90 µg/kg |
|---|---|---|
| 1 dose | 51 | 23 |
| 2 doses | 94 | 62 |
| 3 doses | 195 | 142 |
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.
| events | Vatreptacog Alfa 80 µg/kg | rFVIIa 90 µg/kg |
|---|---|---|
| All adverse events | 55 | 11 |
| Mild adverse events | 33 | 5 |
| Moderate adverse events | 15 | 2 |
| Severe adverse events | 7 | 4 |
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
| Subjects | Vatreptacog Alfa 80 µg/kg | rFVIIa 90 µg/kg |
|---|---|---|
| Positive for anti-vatreptacog alfa | 8 | 0 |
| Cross-reactive with rFVIIa | 4 | 0 |
| Positive for anti-rFVIIa | 0 | 1 |
| In vitro vatreptacog alfa-neutralising | 1 | 0 |
| In vitro FVII/rFVIIa-neutralising | 0 | 0 |
Collected over Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vatreptacog Alfa 80 µg/kg | — | 4/72 (5.6%) | 5/72 (6.9%) |
| rFVIIa 90 µg/kg | — | 4/57 (7%) | 3/57 (5.3%) |
| Event | Vatreptacog Alfa 80 µg/kg | rFVIIa 90 µg/kg |
|---|---|---|
| Retroperitoneal haemorrhageGastrointestinal disorders | 0/72 | 1/57 |
| Small intestinal obstructionGastrointestinal disorders | 0/72 | 1/57 |
| PyelonephritisInfections and infestations | 0/72 | 1/57 |
| Rectal abscessInfections and infestations | 0/72 | 1/57 |
| Arteriovenous fistula thrombosisInjury, poisoning and procedural complications | 0/72 | 1/57 |
| Dental cariesGastrointestinal disorders | 1/72 | 0/57 |
| Lower limb fractureInjury, poisoning and procedural complications | 1/72 | 0/57 |
| TelangiectasiaSkin and subcutaneous tissue disorders | 1/72 | 0/57 |
| HaematomaVascular disorders | 1/72 | 0/57 |
| Event | Vatreptacog Alfa 80 µg/kg | rFVIIa 90 µg/kg |
|---|---|---|
| Drug specific antibody presentInvestigations | 5/72 | 3/57 |
| Age, Continuous(years) | Vatrepcacog Alfa and rFVIIa |
|---|---|
| Mean | 30.19 ± 13.84 |
| Sex: Female, Male(Participants) | Vatrepcacog Alfa and rFVIIa |
|---|---|
| Female | 0 |
| Male | 72 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novo Nordisk A/S