Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (guardian™ 5)
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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. |
| ClinicalTrials.gov Identifier: NCT02035384 |
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Recruitment Status :
Completed
First Posted : January 14, 2014
Last Update Posted : April 27, 2020
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
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Brief Summary:
This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).
| Condition or disease | Intervention/treatment |
|---|---|
| Congenital Bleeding Disorder Haemophilia A | Drug: turoctocog alfa |
| Study Type : | Observational |
| Actual Enrollment : | 69 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Multi-centre Non-interventional Study of Safety and Efficacy of Turoctocog Alfa (rFVIII) During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII =<2%) |
| Actual Study Start Date : | June 5, 2014 |
| Actual Primary Completion Date : | January 15, 2020 |
| Actual Study Completion Date : | January 15, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hemophilia
MedlinePlus related topics:
Hemophilia
Drug Information available for:
Turoctocog alfa
| Group/Cohort | Intervention/treatment |
|---|---|
| All patients |
Drug: turoctocog alfa
Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries. |
Primary Outcome Measures :
- Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors [ Time Frame: Within approximately 7 years ]
Secondary Outcome Measures :
- Number of adverse reactions reported [ Time Frame: During approximately 7 years ]
- Number of serious adverse reactions reported [ Time Frame: During approximately 7 years ]
- Haemostatic effect of turoctocog alfa in the treatment of bleeds as assessed by the patient or the physician according to a predefined four point scale: Excellent, Good, Moderate, or None [ Time Frame: Within approximately 7 years ]
- Haemostatic effect of turoctocog alfa during surgical procedures as assessed by an evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None [ Time Frame: Within approximately 7 years ]
- Annualised bleeding rate for patients using turoctocog alfa for preventive treatment [ Time Frame: Within approximately 7 years ]
- Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment [ Time Frame: Within approximately 7 years ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Previously FVIII treated (more than 150 exposure days) patients with severe and moderately severe haemophilia A with FVIII below or equal to 2%.
Criteria
Inclusion Criteria:
- Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
- Previously FVIII treated (150 exposure days at the time of first dosing with turoctocog alfa) male patients with the diagnosis of severe and moderately severe haemophilia A (FVIII below or equal to 2%)
- The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/parent and the patient's treating physician before and independently from the decision to include the patient in this study
- A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa
Exclusion Criteria:
- Contraindications for use according to the approved product information text (US Package insert (PI), European Summary of Product Characteristics (SmPC), or corresponding local prescribing information)
- Treatment with any investigational drug within 30 days prior to enrolment into the study
- Previous participation in any clinical trial with turoctocog alfa
- Treatment with other FVIII products after initiation of treatment with turoctocog alfa
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): NCT02035384
Locations
| United States, Alabama | |
| Novo Nordisk Investigational Site | |
| Mobile, Alabama, United States, 36604 | |
| United States, California | |
| Novo Nordisk Investigational Site | |
| Torrance, California, United States, 90502-2004 | |
| United States, Illinois | |
| Novo Nordisk Investigational Site | |
| Peoria, Illinois, United States, 61615 | |
| United States, New Mexico | |
| Novo Nordisk Investigational Site | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, North Carolina | |
| Novo Nordisk Investigational Site | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Utah | |
| Novo Nordisk Investigational Site | |
| Salt Lake City, Utah, United States, 84113 | |
| Austria | |
| Novo Nordisk Investigational Site | |
| Graz, Austria, 8036 | |
| Novo Nordisk Investigational Site | |
| Linz, Austria, 4020 | |
| Czechia | |
| Novo Nordisk Investigational Site | |
| Brno, Czechia, 625 00 | |
| France | |
| Novo Nordisk Investigational Site | |
| Bordeaux, France, 33076 | |
| Novo Nordisk Investigational Site | |
| Montmorency, France, 95160 | |
| Novo Nordisk Investigational Site | |
| Rennes, France, 35033 | |
| Novo Nordisk Investigational Site | |
| Saint Etienne, France, 42055 | |
| Novo Nordisk Investigational Site | |
| Strasbourg, France, 67098 | |
| Germany | |
| Novo Nordisk Investigational Site | |
| Braunschweig, Germany, 38118 | |
| Novo Nordisk Investigational Site | |
| Duisburg, Germany, 47051 | |
| Novo Nordisk Investigational Site | |
| Frankfurt / Main, Germany, 60596 | |
| Novo Nordisk Investigational Site | |
| Giessen, Germany, 35392 | |
| Novo Nordisk Investigational Site | |
| Leipzig, Germany, 04289 | |
| Novo Nordisk Investigational Site | |
| Mörfelden-Walldorf, Germany, 64546 | |
| Novo Nordisk Investigational Site | |
| München, Germany, 80331 | |
| Novo Nordisk Investigational Site | |
| Münster, Germany, 48143 | |
| Greece | |
| Novo Nordisk Investigational Site | |
| Athens, Greece, GR-11527 | |
| Hungary | |
| Novo Nordisk Investigational Site | |
| Budapest, Hungary, H-1134 | |
| Novo Nordisk Investigational Site | |
| Debrecen, Hungary, 4032 | |
| Novo Nordisk Investigational Site | |
| Mohács, Hungary, 7700 | |
| Italy | |
| Novo Nordisk Investigational Site | |
| Castelfranco Veneto, Italy, 31033 | |
| Novo Nordisk Investigational Site | |
| Catania, Italy, 95123 | |
| Novo Nordisk Investigational Site | |
| Firenze, Italy, 50134 | |
| Novo Nordisk Investigational Site | |
| Padova, Italy, 35128 | |
| Novo Nordisk Investigational Site | |
| Palermo, Italy, 90127 | |
| Netherlands | |
| Novo Nordisk Investigational Site | |
| Den Haag, Netherlands, 2545AA | |
| Novo Nordisk Investigational Site | |
| Utrecht, Netherlands, 3584 CX | |
| Poland | |
| Novo Nordisk Investigational Site | |
| Warszawa, Poland, 02-091 | |
| Slovakia | |
| Novo Nordisk Investigational Site | |
| Banska Bystrica, Slovakia, 975 17 | |
| Novo Nordisk Investigational Site | |
| Kosice, Slovakia, 04001 | |
| Slovenia | |
| Novo Nordisk Investigational Site | |
| Ljubljana, Slovenia, 1000 | |
| Spain | |
| Novo Nordisk Investigational Site | |
| Barcelona, Spain, 08035 | |
| Sweden | |
| Novo Nordisk Investigational Site | |
| Malmö, Sweden, 205 02 | |
| Novo Nordisk Investigational Site | |
| Stockholm, Sweden, 171 76 | |
| Switzerland | |
| Novo Nordisk Investigational Site | |
| Zürich, Switzerland, 8091 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT02035384 |
| Other Study ID Numbers: |
NN7008-3553 U1111-1126-0353 ( Other Identifier: WHO ) ENCEPP/SDPP/5501 ( Registry Identifier: EU PAS ) |
| First Posted: | January 14, 2014 Key Record Dates |
| Last Update Posted: | April 27, 2020 |
| Last Verified: | April 2020 |
Additional relevant MeSH terms:
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Hemostatic Disorders Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Vascular Diseases Cardiovascular Diseases |