Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A (pathfinder™1)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01205724
First received: September 17, 2010
Last updated: June 29, 2012
Last verified: June 2012
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Purpose
This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Bleeding Disorder Haemophilia A |
Drug: NNC 0129-0000-1003 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-National, Open-Label, Dose Escalation Trial, Evaluating Safety and Pharmacokinetics of Intravenous Doses of NNC 0129-0000-1003 in Patients With Haemophilia A |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Frequency of adverse events (AEs) reported after administration of trial product [ Time Frame: up to four weeks after trial product administration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample) [ Time Frame: from 0 to 168 hours after trial product administration ] [ Designated as safety issue: No ]
- Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments [ Time Frame: up to four weeks after trial product administration ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | September 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: NNC 0129-0000-1003
Single dose (low) administered intravenously (into the vein)
|
| Experimental: B |
Drug: NNC 0129-0000-1003
Single dose (medium) administered intravenously (into the vein)
|
| Experimental: C |
Drug: NNC 0129-0000-1003
Single dose (high) administered intravenously (into the vein)
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Haemophilia A
- Body Mass Index (BMI) below 35 kg/m2
- History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand)
Exclusion Criteria:
- Any history of FVIII inhibitors
- Surgery planned to occur during the trial
- Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
- Congenital or acquired coagulation disorders other than haemophilia A
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205724
Locations
| United States, Iowa | |
| Novo Nordisk Clinical Trial Call Center | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Novo Nordisk Clinical Trial Call Center | |
| Lexington, Kentucky, United States, 40536 | |
| Novo Nordisk Clinical Trial Call Center | |
| Lexington, Kentucky, United States, 40526- 0293 | |
| United States, Maryland | |
| Novo Nordisk Clinical Trial Call Center | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Pennsylvania | |
| Novo Nordisk Clinical Trial Call Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Germany | |
| Hannover, Germany, 30625 | |
| Italy | |
| Vicenza, Italy, 36100 | |
| Japan | |
| Shinjuku-ku, Tokyo, Japan, 160 0023 | |
| Switzerland | |
| Zürich, Switzerland, 8091 | |
| Turkey | |
| Bornova-IZMIR, Turkey, 35100 | |
| United Kingdom | |
| London, United Kingdom, NW3 2QG | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Dorthe Viuff | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01205724 History of Changes |
| Other Study ID Numbers: | NN7088-3776, 2010-018520-68, U1111-1116-2043, JapicCTI-101293 |
| Study First Received: | September 17, 2010 |
| Last Updated: | June 29, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medicinal Devices (BfarM) Italy: Ministry of Health Japan: Ministry of Health, Labor and Welfare Russia: Federal Service for Control of Health Care and Social Development Switzerland: Swissmedic Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hematologic Diseases Vascular Diseases Cardiovascular Diseases Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Genetic Diseases, Inborn |
Hemophilia A Hemorrhage Pathologic Processes Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013