Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00837356
First received: February 4, 2009
Last updated: June 29, 2012
Last verified: June 2012
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Purpose
This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, N8 with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Bleeding Disorder Haemophilia A |
Drug: Advate® Drug: recombinant factor VIII (N8) Procedure: Blood drawn for laboratory testing |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Recovery of FVIII 30 min after administration, half-life, AUC, and clearance [ Time Frame: at 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Inhibitor development [ Time Frame: at 30 days ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | March 2009 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Advate®
Subjects will receive Advate® at a dose of 50IU/kg body weight in the first session.
Drug: recombinant factor VIII (N8)
After a washout period of 4 days, subjects will subsequently receive recombinant factor VIII (N8) at a dose of 50 IU/kg body weight in the second session.
Other Names:
Procedure: Blood drawn for laboratory testing
Blood drawn for laboratory testing
|
Eligibility| Ages Eligible for Study: | 12 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Severe haemophilia A (FVIII level less than or equal to 1%)
- Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
- HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial
Exclusion Criteria:
- Presence of any bleeding disorder in addition to haemophilia A
- Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
- Abnormal renal function tests
- Known hypersensitivity to Advate®
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837356
Locations
| Germany | |
| Hannover, Germany, 30625 | |
| Israel | |
| Tel-Hashomer, Israel, 52621 | |
| Italy | |
| Milano, Italy, 20124 | |
| Switzerland | |
| Zürich, Switzerland, 8091 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Marianne Willert, MSc | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT00837356 History of Changes |
| Other Study ID Numbers: | NN7008-3522, 2008-002157-21 |
| Study First Received: | February 4, 2009 |
| Last Updated: | June 29, 2012 |
| Health Authority: | Israel: Ministry of Health Italy: National Institute of Health Switzerland: Swissmedic Germany: Paul-Ehrlich-Institut |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemophilia A Hemorrhage Hematologic Diseases Vascular Diseases Cardiovascular Diseases Blood Coagulation Disorders, Inherited |
Coagulation Protein Disorders Genetic Diseases, Inborn Pathologic Processes Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013