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

NCT01876745 | Completed

• 2 other identifiers: F7HAEM-4030U1111-1139-9589
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Bleeding Disorder; Glanzmann's Disease

Outcome Measures

Primary Outcomes (1)

• Therapy-related thrombosis

  From onset of treatment until 6 hours after treatment onset

Secondary Outcomes (2)

• 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

  Within 24 hours after surgery for surgery/delivery

Study Arms (1)

NovoSeven® (activated recombinant factor VII)

Drug: eptacog alfa (activated)

Interventions

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.

Also known as: activated recombinant factor VII, NovoSeven®

NovoSeven® (activated recombinant factor VII)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Thrombasthenia

Interventions

Factor VII; recombinant FVIIa

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 13, 2013
• Study Start: October 7, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

JP (1)