Trial record 2 of 7 for:    "Thrombasthenia"

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01876745
First received: May 31, 2013
Last updated: March 13, 2014
Last verified: March 2014
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876745

Locations
Japan
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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01876745     History of Changes
Other Study ID Numbers: F7HAEM-4030, U1111-1139-9589
Study First Received: May 31, 2013
Last Updated: March 13, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Thrombasthenia
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014