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Trial record 2 of 8 for:    "Thrombasthenia"

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01876745
First Posted: June 13, 2013
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention
Congenital Bleeding Disorder Glanzmann's Disease Drug: eptacog alfa (activated)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multicentre, Non-interventional, Observational Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Therapy-related thrombosis [ Time Frame: From onset of treatment until 6 hours after treatment onset ]

Secondary Outcome Measures:
  • Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate [ Time Frame: 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 [ Time Frame: Within 24 hours after surgery for surgery/delivery ]

Enrollment: 4
Actual Study Start Date: October 7, 2014
Study Completion Date: June 1, 2017
Primary Completion Date: June 1, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NovoSeven® (activated recombinant factor VII) Drug: eptacog alfa (activated)
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.
Other Names:
  • activated recombinant factor VII
  • NovoSeven®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876745


Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01876745     History of Changes
Other Study ID Numbers: F7HAEM-4030
U1111-1139-9589 ( Other Identifier: WHO )
First Submitted: May 31, 2013
First Posted: June 13, 2013
Last Update Posted: July 11, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Thrombasthenia
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Genetic Diseases, Inborn