Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01692925
First received: September 21, 2012
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Bleeding Disorder Haemophilia A |
Drug: turoctocog alfa 2000 IU/vial Drug: turoctocog alfa 3000 IU/vial |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay [ Time Frame: up to 48 hours after i.v. administration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay [ Time Frame: up to 48 hours after i.v. administration ] [ Designated as safety issue: No ]
- Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg]) [ Time Frame: up to 48 hours after i.v. administration ] [ Designated as safety issue: No ]
- Area under the FVIII activity-time curve (AUC) [ Time Frame: up to 48 hours after i.v. administration ] [ Designated as safety issue: No ]
- Terminal half-life of FVIII (t½) [ Time Frame: up to 48 hours after i.v. administration ] [ Designated as safety issue: No ]
- Clearance of FVIII (CL) [ Time Frame: up to 48 hours after i.v. administration ] [ Designated as safety issue: No ]
- Incidence of adverse events (AEs) including FVIII inhibitors [ Time Frame: After approximately 3 months (at end of trial) ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | December 2012 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lot A |
Drug: turoctocog alfa 2000 IU/vial
Trial product will be administered as an i.v. (intravenous) bolus injection. Each subject will receive two single doses of turocotocog alfa from two lots of trial product.
|
| Experimental: Lot B |
Drug: turoctocog alfa 2000 IU/vial
Trial product will be administered as an i.v. (intravenous) bolus injection. Each subject will receive two single doses of turocotocog alfa from two lots of trial product.
|
| Experimental: Lot C |
Drug: turoctocog alfa 2000 IU/vial
Trial product will be administered as an i.v. (intravenous) bolus injection. Each subject will receive two single doses of turocotocog alfa from two lots of trial product.
|
| Experimental: Lot D |
Drug: turoctocog alfa 3000 IU/vial
Trial product will be administered as an i.v. (intravenous) bolus injection. Each subject will receive two single doses of turocotocog alfa from two lots of trial product.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male subjects with the diagnosis of severe haemophilia A (FVIII<1%) from age 18 years
- Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
- Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count >200/microL)
Exclusion Criteria:
- Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))
- History of FVIII inhibitors
- Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
- Known or suspected allergy to trial product (FVIII) or related products
- Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens
- Body mass index(BMI) above 30 kg/m^2
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01692925 History of Changes |
| Other Study ID Numbers: | NN7008-4015, 2012-001444-21, U1111-1129-1517 |
| Study First Received: | September 21, 2012 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Latvia: Ministry of Health Spain: Spanish Agency of Medicines and Health Care Products |
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 June 18, 2013