Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A (pathfinder™1)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01205724
First received: September 17, 2010
Last updated: June 29, 2012
Last verified: June 2012
  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 A/S:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
Investigators
Study Director: Dorthe Viuff Novo Nordisk A/S
  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 July 29, 2014