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NCT01476423 Clinical Trial

Observational Registry of the Treatment of Glanzmann's Thrombasthenia

Congenital Bleeding Disorder Clinical Trial

Official title:
Treatment of Glanzmann's Thrombasthenia: A Prospective Observational Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01476423
Other study ID # F7HAEM-3521
Secondary ID U1111-1122-5019
Status Completed
Phase N/A
First received October 7, 2011
Last updated December 19, 2014
Start date January 2004
Est. completion date October 2011

Study information
Verified date December 2014
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Algeria: Ministry of HealthAustria: Not required for observational study in AustriaBelgium: Not required for observational study in BelgiumBulgaria: Ministry of HealthFrance: Not required for observational studyGermany: Not required for observational studyHungary: Not required for observational studyItaly: Not required for observational studyNetherlands: Dutch Health Care InspectoratePakistan: Not required for observational studySpain: Ministry of HealthSweden: Not required for observational studySwitzerland: SwissmedicUnited Kingdom: Not required for observational studyUnited States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

This observational registry is conducted in Europe, Asia, Africa and the United States of America (USA).

The purpose of the registry is to evaluate the efficacy and safety of activated recombinant human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or present refractoriness to platelet transfusions. Attention will be directed towards complications related to thrombo-embolic events and concomitant medications especially antifibrinolytics.

Recruitment information / eligibility
Status Completed
Enrollment 218
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with congenital GT defined as patients with lifelong bleeding tendency characterised by impaired or absent platelet aggregation, impaired clot retraction and prolonged bleeding time or prolonged platelet function analyser closure time. The patient has normal platelet counts and platelet morphology. Optional diagnosis criteria are quantitative or qualitative evaluation of GP (Glycoprotein) IIb/IIIa receptor including flow cytometry and identification of gene defects

- Signed informed consent by the patient or next of kin or legally acceptable representative to collect data on treatment of a given bleeding episode or surgical event as specified in the protocol. If informed consent is provided by the next of kin or legally acceptable representative, consent must also be obtained from the patient as soon as he/she is able to do so. Informed consent must be obtained before entry of data into the registry

Exclusion Criteria:

- Patients with acquired thrombasthenic states caused by autoimmune disorders (acute or chronic) or drugs

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• activated recombinant human factor VII
A prospective, observational multi-national registry collecting data and evaluating the efficacy and safety of rFVIIa in patients with GT with past or present refractoriness to platelet transfusions. The registry will also collect data from a broader range of GT patients treated with systemic haemostatic treatment (with or without antifibrinolytic drugs or other agents) used in the clinics. Data collection will continue for a maximum of six years. Baseline data as well as data obtained during either bleeding episodes or invasive procedures/surgeries will be recorded in the registry.

Locations
Country Name City State
United States Novo Nordisk Clinical Trial Call Center Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Algeria,  Austria,  Belgium,  Bulgaria,  France,  Germany,  Hungary,  Italy,  Netherlands,  Pakistan,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary For bleeding episodes: Overall efficacy evaluated by the caregiver/patient within 30 days of end of treatment No
Primary For surgery including invasive and dental procedures: Haemoglobin level prior to surgery and 24 hours after surgery No
Primary For surgery including invasive and dental procedures: Overall haemostatic evaluation by the surgeon 24 hours after surgery No
Secondary Changes in laboratory parameters (prothrombin time, platelet count, fibrinogen), if available at the time of administration and two hours after the administration of rFVIIa No
Secondary Adverse Events (AEs) during treatment episodes No
Secondary Serious Adverse Events (SAEs) during treatment episodes No
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Completed NCT00951405 - Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors Phase 2
Completed NCT01876745 - A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan N/A
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Completed NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 Phase 3
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT01779921 - Treatment of Congenital Factor VII Deficiency N/A
Completed NCT01563471 - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers Phase 1
Completed NCT02941354 - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A Phase 1
Completed NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01220141 - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B N/A

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