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
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01234545
First received: November 3, 2010
Last updated: April 8, 2013
Last verified: April 2013
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Purpose
This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.
| Condition | Intervention |
|---|---|
|
Congenital Bleeding Disorder Haemophilia A Haemophilia B |
Drug: activated recombinant human factor VII |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective Observational Study on the Home Treatment of Haemarthrosis With rFVIIa (Activated Recombinant Factor VII) in Haemophilia A and 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:
- Number of bleeds managed at home [ Time Frame: Month 8 ] [ Designated as safety issue: No ]
- Number of treatments resulting in the control of bleeding episode [ Time Frame: within 9 hours after the first injection of study product ] [ Designated as safety issue: No ]
- Number of treatments resulting in effective pain relief [ Time Frame: within 9 hours after the first injection of study product ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home [ Time Frame: Month 8 ] [ Designated as safety issue: No ]
- Proportion of patients who used their entire treatment at home [ Time Frame: Month 8 ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | October 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| A |
Drug: activated recombinant human factor VII
Prescription is done at the discretion of the prescribing physician as part of normal clinical routine
|
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with congenital haemophilia and inhibitors to Factor VIII or IX.
Criteria
Inclusion Criteria:
- Patients with congenital haemophilia and inhibitors to factor VIII or IX
- Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle
Exclusion Criteria:
- Known or suspected allergy to study product(s) or related products
- Clinically relevant coagulation disorders other than congenital haemophilia A or B
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234545
Locations
| Algeria | |
| Algiers, Algeria, 16035 | |
| Morocco | |
| Casablanca, Morocco, 20000 | |
| Oman | |
| Muscat, Oman | |
| Saudi Arabia | |
| Riyadh, Saudi Arabia, 3542 | |
| United Arab Emirates | |
| Dubai, United Arab Emirates | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Hossam Ali | Novo Nordisk Pharma Gulf |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01234545 History of Changes |
| Other Study ID Numbers: | F7HAEM-3850, U1111-1116-2488 |
| Study First Received: | November 3, 2010 |
| Last Updated: | April 8, 2013 |
| Health Authority: | Algeria: Ministry of Health Morocco: Ministry of Health Saudi Arabia: Ministry of Health Oman: Ministry of Health United Arab Emirates: Ministry of Health |
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