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 evaluateOverall 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
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