Observational Registry of the Treatment of Glanzmann's Thrombasthenia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Congenital Bleeding Disorder Glanzmann's Disease |
Drug: No treatment given |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Treatment of Glanzmann's Thrombasthenia: A Prospective Observational Registry |
- For bleeding episodes: Overall efficacy evaluated by the caregiver/patient [ Time Frame: within 30 days of end of treatment ] [ Designated as safety issue: No ]
- For surgery including invasive and dental procedures: Haemoglobin level [ Time Frame: prior to surgery and 24 hours after surgery ] [ Designated as safety issue: No ]
- For surgery including invasive and dental procedures: Overall haemostatic evaluation by the surgeon [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
- Changes in laboratory parameters (prothrombin time, platelet count, fibrinogen), if available [ Time Frame: at the time of administration and two hours after the administration of rFVIIa ] [ Designated as safety issue: No ]
- Adverse Events (AEs) [ Time Frame: during treatment episodes ] [ Designated as safety issue: No ]
- Serious Adverse Events (SAEs) [ Time Frame: during treatment episodes ] [ Designated as safety issue: No ]
| Enrollment: | 218 |
| Study Start Date: | May 2007 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| A |
Drug: No treatment given
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.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with GT. There is no limit to the number of bleeding episodes or preventions of bleeding during invasive procedures/surgery that can be entered for each patient within the lifetime of the registry. Patients will receive standard care according to local practice, thus any systemic haemostatic treatment (with or without antifibrinolytic drugs or other agents) considered useful by the centres for treatment of GT, are included in the registry.
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
Contacts and Locations| United States, New Jersey | |
| Novo Nordisk Clinical Trial Call Center | |
| Princeton, New Jersey, United States, 08540 | |
| Algeria | |
| Algiers, Algeria, 16035 | |
| Austria | |
| Vienna, Austria, A-1010 | |
| Belgium | |
| Brussels, Belgium, 1070 | |
| Bulgaria | |
| Sofia, Bulgaria, 1407 | |
| France | |
| Paris La défense cedex, France, 92932 | |
| Germany | |
| Mainz, Germany, 55127 | |
| Hungary | |
| Budapest, Hungary, H-1025 | |
| Italy | |
| Rome, Italy, 00144 | |
| Netherlands | |
| Alphen a/d Rijn, Netherlands | |
| Pakistan | |
| Karachi, Pakistan | |
| Spain | |
| Madrid, Spain, 28033 | |
| Sweden | |
| Malmö, Sweden, SE-202 15 | |
| Switzerland | |
| Zurich, Switzerland, CH-8050 | |
| United Kingdom | |
| Crawley, United Kingdom, RH11 9RT | |
| Study Director: | Nicola M. Wennerwald | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01476423 History of Changes |
| Other Study ID Numbers: | F7HAEM-3521, U1111-1122-5019 |
| Study First Received: | October 7, 2011 |
| Last Updated: | March 19, 2012 |
| Health Authority: | Algeria: Ministry of Health Austria: Not required for observational study in Austria Belgium: Not required for observational study in Belgium Bulgaria: Ministry of Health France: Not required for observational study Germany: Not required for observational study Hungary: Not required for observational study Italy: Not required for observational study Netherlands: Dutch Health Care Inspectorate Pakistan: Not required for observational study Spain: Ministry of Health Sweden: Not required for observational study Switzerland: Swissmedic United Kingdom: Not required for observational study United States: Food and Drug Administration |
Keywords provided by Novo Nordisk:
|
Glanzmann's Thrombasthenia |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemorrhage Thrombasthenia Hematologic Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Blood Coagulation Disorders, Inherited Blood Platelet Disorders Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on June 18, 2013