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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01561417
Other study ID # NN1007-1744
Secondary ID 2005-005379-14
Status Completed
Phase Phase 1
First received March 21, 2012
Last updated January 18, 2017
Start date April 2006
Est. completion date September 2006

Study information

Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Caucasian

- Body Mass Index (BMI) between 18 and 27 kg/m^2, both inclusive

- Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results

- Smoke less than 10 cigarettes (or equivalent) per day

- Capable of giving written Informed Consent (IC)

Exclusion Criteria:

- Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator

- Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I

- Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation

- Overt bleeding, including from gastrointestinal tract

- Hepatitis (B or C) infection

- HIV (human immunodeficiency virus) infection

Study Design


Intervention

Drug:
activated recombinant human factor VII
One single dose administration, injected i.v. (into the vein)
activated recombinant human factor VII
One single dose administration, injected i.v. (into the vein)

Locations

Country Name City State
France Novo Nordisk Investigational Site Paris

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

References & Publications (1)

Bysted BV, Scharling B, Møller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25 degrees C stable formulation. Haemophilia. 2007 Sep;13(5):527-32. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration versus time curve for FVIIa clot activity
Secondary The maximum plasma concentration (Cmax)
Secondary Terminal half-life (t½)
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