Trial · NCT00486278

Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

NCT00486278, Phase 2, Completed, Novo Nordisk A/S; results first posted 2014-12-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds. Trials, record NCT00486278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00486278

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
NCT number: NCT00486278
Status: Completed
Phases: Phase 2
Enrollment: 51 participants, actual
Lead sponsor: Novo Nordisk A/S
Conditions: Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
Interventions: eptacog alfa (activated), vatreptacog alfa (activated), vatreptacog alfa (activated), vatreptacog alfa (activated), vatreptacog alfa (activated), vatreptacog alfa (activated)
First posted: 2007-06-14
Last updated: 2017-03-07
Other registries' IDs: eudract:2006-004879-35
Results first posted: 2014-12-25

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Adverse Events (AEs)	Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.	Adverse event is defined as 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.
Secondary	Activated Recombinant Human Factor VII Analogue Activity in the Blood	0-24 hours after trial product administration
Secondary	Prothrombin Time (PT)	pre-dose - 12 hours after trial product administration	The test measures the clotting time of plasma following the activation of tissue factor (TF also called thromboplastin) and calcium to hypocalcemic plasma. PT was provided in percent based on the measured PT in seconds and related/converted with the relevant standard curve. The percent value was derived based on the hyperbolic relation between PT (sec) and % PT activity.
Secondary	F1 + 2 (Prothrombin Fragments 1+2)	pre-dose - 12 hours after trial product administration	Thrombin and F1+2 are formed in equimolar quantities by the enzymatic cleavage of prothrombin (FII), and F1+2 thus indicate that thrombin has been generated.
Secondary	Activated Partial Thromboplastin Time (aPTT)	pre-dose - 12 hours after trial product administration	The aPTT time measured in clinical samples reflects both the effect of the drugs (generation of thrombin and FXa) and the presence of rFVIIa /rFVIIa analogue in the plasma samples causing a dose dependent shortening of the clotting time.
Secondary	Cessation of Bleeding: Number of Doses Needed to Control Bleeding	Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure)
Secondary	Number of Subjects With Need for Additional Haemostatic Agents	within 24 hours after successful control of bleeding episode with trial product
Secondary	Pharmacokinetic Parameters Based on FVIIa Activity: AUC 0-t (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to the Time (t) )	0-24 hours after trial product administration
Secondary	Pharmacokinetic Parameters Based on FVIIa Activity: AUC(0-inf) (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to Infinity)	0-24 hours after trial product administration
Secondary	Pharmacokinetic Parameters Based on FVIIa Activity: MRT (Mean Residence Time)	0-24 hours after trial product administration

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Adverse Events (AEs)	Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.	Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.	events	NUMBER
SECONDARY	Activated Recombinant Human Factor VII Analogue Activity in the Blood	0-24 hours after trial product administration	All randomised patients in top three dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violation of the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set.	IU/mL	MEAN
SECONDARY	Prothrombin Time (PT)	pre-dose - 12 hours after trial product administration	Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.	percentage (%)	MEAN
SECONDARY	F1 + 2 (Prothrombin Fragments 1+2)	pre-dose - 12 hours after trial product administration	Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.	pmol/L	MEAN
SECONDARY	Activated Partial Thromboplastin Time (aPTT)	pre-dose - 12 hours after trial product administration	Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.	Sec	MEAN
SECONDARY	Cessation of Bleeding: Number of Doses Needed to Control Bleeding	Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure)	All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 1 subject did not contribute to the data.	bleeding episodes	NUMBER
SECONDARY	Number of Subjects With Need for Additional Haemostatic Agents	within 24 hours after successful control of bleeding episode with trial product	All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 9 subjects did not contribute to the data.	participants	NUMBER
SECONDARY	Pharmacokinetic Parameters Based on FVIIa Activity: AUC 0-t (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to the Time (t) )	0-24 hours after trial product administration	All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.	(IU*h)/mL	GEOMETRIC_MEAN
SECONDARY	Pharmacokinetic Parameters Based on FVIIa Activity: AUC(0-inf) (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to Infinity)	0-24 hours after trial product administration	All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.	(IU*h)/mL	GEOMETRIC_MEAN
SECONDARY	Pharmacokinetic Parameters Based on FVIIa Activity: MRT (Mean Residence Time)	0-24 hours after trial product administration	All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.	hours	MEAN

1 to 10 of 21Source ClinicalTrials.gov

See all 21 outcomes

Results by group268

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Adverse Events (AEs)	Vatreptacog Alfa 5 mcg/kg	All AEs	10	events
Number of Adverse Events (AEs)	Vatreptacog Alfa 10 mcg/kg	All AEs	8	events
Number of Adverse Events (AEs)	Vatreptacog Alfa 20 mcg/kg	All AEs	5	events
Number of Adverse Events (AEs)	Vatreptacog Alfa 40 mcg/kg	All AEs	5	events
Number of Adverse Events (AEs)	Vatreptacog Alfa 80 mcg/kg	All AEs	0	events
Number of Adverse Events (AEs)	rFVIIa 90 mcg/kg	All AEs	11	events
Number of Adverse Events (AEs)	Vatreptacog Alfa 5 mcg/kg	Serious AEs	3	events
Number of Adverse Events (AEs)	Vatreptacog Alfa 10 mcg/kg	Serious AEs	5	events
Number of Adverse Events (AEs)	Vatreptacog Alfa 20 mcg/kg	Serious AEs	2	events
Number of Adverse Events (AEs)	Vatreptacog Alfa 40 mcg/kg	Serious AEs	2	events

1 to 10 of 268Source ClinicalTrials.gov

See all 268 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	All Subjects	51
Overall Study	COMPLETED	All Subjects	42
Overall Study	NOT COMPLETED	All Subjects	9

Source ClinicalTrials.gov

Adverse events204

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Vatreptacog Alfa 5 mcg/kg	0	16	0
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Vatreptacog Alfa 10 mcg/kg	0	19	0
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Vatreptacog Alfa 20 mcg/kg	0	16	0
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Vatreptacog Alfa 40 mcg/kg	0	16	0
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Vatreptacog Alfa 80 mcg/kg	0	10	0
other	Iron deficiency anaemia	Blood and lymphatic system disorders	rFVIIa 90 mcg/kg	1	19	1
other	Diarrhoea	Gastrointestinal disorders	Vatreptacog Alfa 5 mcg/kg	0	16	0
other	Diarrhoea	Gastrointestinal disorders	Vatreptacog Alfa 10 mcg/kg	2	19	2
other	Diarrhoea	Gastrointestinal disorders	Vatreptacog Alfa 20 mcg/kg	0	16	0
other	Diarrhoea	Gastrointestinal disorders	Vatreptacog Alfa 40 mcg/kg	0	16	0

1 to 10 of 204Source ClinicalTrials.gov

See all 204 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vatreptacog Alfa 5 mcg/kg
Total, all-cause mortality	Vatreptacog Alfa 10 mcg/kg
Total, all-cause mortality	Vatreptacog Alfa 20 mcg/kg
Total, all-cause mortality	Vatreptacog Alfa 40 mcg/kg
Total, all-cause mortality	Vatreptacog Alfa 80 mcg/kg
Total, all-cause mortality	rFVIIa 90 mcg/kg
Total, other adverse events	Vatreptacog Alfa 5 mcg/kg	6	16
Total, other adverse events	Vatreptacog Alfa 10 mcg/kg	3	19
Total, other adverse events	Vatreptacog Alfa 20 mcg/kg	3	16
Total, other adverse events	Vatreptacog Alfa 40 mcg/kg	1	16

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22470921	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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