A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01238367
First received: November 9, 2010
Last updated: October 16, 2012
Last verified: October 2012
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Purpose
This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of recombinant factor VIII (N8) in Japanese subjects with haemophilia A.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Bleeding Disorder Haemophilia A |
Drug: recombinant factor VIII (N8) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multi-centre, Open-label, Non-randomised Single Dose Trial Investigating the Pharmacokinetics of N8 in Japanese Subjects With Haemophilia A |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Area under the curve [ Time Frame: Infusion, 30 minutes ] [ Designated as safety issue: No ]
- Incremental recovery [ Time Frame: Infusion, 30 minutes ] [ Designated as safety issue: No ]
- In vivo t1/2 [ Time Frame: Infusion, 30 minutes ] [ Designated as safety issue: No ]
- Total clearance (CL) [ Time Frame: Infusion, 30 minutes ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Maximal concentration [ Time Frame: at 15 minutes ] [ Designated as safety issue: No ]
- Area under the curve [ Time Frame: from time zero to last ] [ Designated as safety issue: No ]
- Number of adverse events [ Time Frame: from day -1 to day 3 (end of trial) ] [ Designated as safety issue: No ]
| Enrollment: | 6 |
| Study Start Date: | November 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: recombinant factor VIII |
Drug: recombinant factor VIII (N8)
Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection
|
Eligibility| Ages Eligible for Study: | 12 Years to 66 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Japanese subjects who have completed NN7008-3543
- No detectable inhibitors to factor VIII
Exclusion Criteria:
- Congenital or acquired coagulation disorders other than haemophilia A
- Planned surgery during the trial period
- Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01238367 History of Changes |
| Other Study ID Numbers: | NN7008-3600, U1111-1117-1286, JapicCTI-101346 |
| Study First Received: | November 9, 2010 |
| Last Updated: | October 16, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 16, 2013