Bioequivalence of NovoSeven® and a NovoSeven® Formulation... | NCT01561417

Studies
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects

NCT01561417

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 19, 2017Estimated

Enrollment

28Actual

Phase

Phase 1

Conditions

Acquired Bleeding Disorder
Acquired Haemophilia
Congenital Bleeding Disorder
Congenital FVII Deficiency
Glanzmann's Disease
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Healthy

Interventions

activated recombinant human factor VII
activated recombinant human factor VII

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2005-005379-14	EudraCT Number

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2006Actual

First Submitted Date

Mar 21, 2012

First Submission Date that Met QC Criteria

Mar 21, 2012

First Posted Date

Mar 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2017

Last Update Posted Date

Jan 19, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Conditions Module

Conditions

Acquired Bleeding Disorder
Acquired Haemophilia
Congenital Bleeding Disorder
Congenital FVII Deficiency
Glanzmann's Disease
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Healthy

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CP-rFVIIa	Active Comparator		Drug: activated recombinant human factor VII
VII25	Experimental		Drug: activated recombinant human factor VII

Interventions

Name	Type	Description	Arm Group Labels	Other Names
activated recombinant human factor VII	Drug	One single dose administration, injected i.v. (into the vein)	CP-rFVIIa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration versus time curve for FVIIa clot activity

Secondary Outcomes

Measure	Description	Time Frame
The maximum plasma concentration (Cmax)
Terminal half-life (t½)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Paris		75015	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17880439	Result	Bysted BV, Scharling B, Moller 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. doi: 10.1111/j.1365-2516.2007.01516.x.

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D001791	Blood Platelet Disorders
D006474	Hemorrhagic Disorders
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities