Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01561924
First received: March 21, 2012
Last updated: June 15, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors |
Drug: activated recombinant human factor VII |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | An Exploratory Non-interventional Study of Ex-vivo Spiking Followed by Thromboelastography as a Method for Predicting the Efficacy of Recombinant Activated Human FVII (rFVIIa, NovoSeven®) in Adult Congenital Haemophilia A or B Patients With Inhibitors |
Resource links provided by NLM:
Genetics Home Reference related topics:
hemophilia
Drug Information available for:
Eptacog alfa
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- TEG parameters obtained at baseline and with activated recombinant human factor VII [ Designated as safety issue: No ]
- ROTEM parameters obtained at baseline and with activated recombinant human factor VII [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | November 2005 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ex vivo |
Drug: activated recombinant human factor VII
Subjects will be called to attend the clinic in a non-bleeding state. Blood samples will be drawn for thromboelastogram profiling and will be in-vitro spiked with different doses of activatated recombinant human factor VII.
|
Detailed Description:
The TEG parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT)
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C clot activity or FIX:C clot activity, respectively, less than 5%
- Presently use of activated recombinant human factor VII (NovoSeven®) as haemostatic agent for preventive treatment or treatment of bleeding episodes
- A documented historical or present record for the presence of inhibitors to factor VIII or IX, respectively
- A documented history of 2 or more joint bleeding episodes during the preceding 12 months
- Subjects must be in a non-bleeding state (i.e. no clinical manifestations of active bleeds)
Exclusion Criteria:
- Subjects who have received any haemostatic treatment for a bleeding episode within the last 7 days prior to this trial
- Immune tolerance therapy within the last 30 days prior to this trial
- Clinically relevant coagulation disorders other than congenital haemophilia A or B
- Thrombocytopenia (platelet count below 60,000 platelets/mcl)
- Prophylactic haemostatic treatment within 3 days prior to this trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561924
Locations
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| Berkeley, California, United States, 94704 | |
| United States, Iowa | |
| Novo Nordisk Clinical Trial Call Center | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Pennsylvania | |
| Novo Nordisk Clinical Trial Call Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Denmark | |
| Århus N, Denmark, 8200 | |
| France | |
| Lyon, France, 69003 | |
| United Kingdom | |
| London, United Kingdom, E1 2AD | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Erik Andersen | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01561924 History of Changes |
| Other Study ID Numbers: | F7HAEM-1675 |
| Study First Received: | March 21, 2012 |
| Last Updated: | June 15, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemophilia B Hemophilia A Hemorrhage Hematologic Diseases Vascular Diseases Cardiovascular Diseases Blood Coagulation Disorders, Inherited |
Coagulation Protein Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked Pathologic Processes Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013