A Study to Evaluate Safety and Efficacy of NovoSeven® in... | NCT01876745

Studies
A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan

NCT01876745

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jul 11, 2017Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Congenital Bleeding Disorder
Glanzmann's Disease

Interventions

eptacog alfa (activated)

Countries

Japan

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1139-9589	Other Identifier	WHO

Status Module

Record Verification Date

Jul 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

Oct 7, 2014Actual

Primary Completion Date

Jun 1, 2017Actual

Completion Date

Jun 1, 2017Actual

First Submitted Date

May 31, 2013

First Submission Date that Met QC Criteria

Jun 12, 2013

First Posted Date

Jun 13, 2013Estimated

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

Jul 10, 2017

Last Update Posted Date

Jul 11, 2017Actual

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 study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NovoSeven® (activated recombinant factor VII)			Drug: eptacog alfa (activated)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
eptacog alfa (activated)	Drug	Patients will be treated according to routine clinical practice at the direction of the treating physician. Data will be collected once a year after patient is registered with baseline visit until end of the study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Therapy-related thrombosis		From onset of treatment until 6 hours after treatment onset

Secondary Outcomes

Measure	Description	Time Frame
Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate		Within 30 days of end of treatment for bleeding episodes
Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent obtained before any study-related activities (Study related activity are any procedure related to recording of data according to the protocol).
All-treated patients in the registration period

Exclusion Criteria:

Known or suspected allergy to study product(s) or related products
Septicaemia (especially, septicaemia followed severely infected patients caused by gram-negative bacteria [The risk of DIC (disseminated intravascular coagulation) caused by endotoxemia could not denied]
Patients with a history of hypersensitivity to any of the product components

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with GT, who are enrolled in this study and to whom activated recombinant human factor VII (NovoSeven®) is administered in the study period, shall be included.

Sampling Method

Non-Probability Sample

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		Tokyo		1000005	Japan

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D013915	Thrombasthenia

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005167	Factor VII
C103587	recombinant FVIIa

Ancestor Terms

ID	Term
D004792	Enzyme Precursors
D045762	Enzymes and Coenzymes
D001779	Blood Coagulation Factors
D001798	Blood Proteins

Browse Leaves

Not provided

Browse Branches

Not provided