DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congenital Bleeding Disorder; Glanzmann's Disease

Intervention: eptacog alfa (activated) (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

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.

Clinical Details

Official title: A Multicentre, Non-interventional, Observational Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Therapy-related thrombosis

Secondary outcome:

Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate

Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Tokyo 1000005, Japan
Additional Information

Clinical Trials at Novo Nordisk

Starting date: October 2014
Last updated: August 18, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017