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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01205724
First received: September 17, 2010
Last updated: February 9, 2017
Last verified: February 2017
  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: turoctocog alfa pegol
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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 ]

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 ]
  • Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments [ Time Frame: up to four weeks after trial product administration ]

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: turoctocog alfa pegol
Single dose (low) administered intravenously (into the vein)
Other Name: NNC 0129-0000-1003
Experimental: B Drug: turoctocog alfa pegol
Single dose (medium) administered intravenously (into the vein)
Other Name: NNC 0129-0000-1003
Experimental: C Drug: turoctocog alfa pegol
Single dose (high) administered intravenously (into the vein)
Other Name: NNC 0129-0000-1003

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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 Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40536
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21287
United States, Pennsylvania
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Germany
Novo Nordisk Investigational Site
Frankfurt/M., Germany, 60590
Novo Nordisk Investigational Site
Giessen, Germany, 35392
Novo Nordisk Investigational Site
Hannover, Germany, 30625
Italy
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Vicenza, Italy, 36100
Japan
Novo Nordisk Investigational Site
Kashihara-shi, Nara, Japan, 634 8522
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, Japan, 466 8560
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160 0023
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
Turkey
Novo Nordisk Investigational Site
Bornova-IZMIR, Turkey, 35100
United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom, NW3 2QG
Novo Nordisk Investigational Site
London, United Kingdom, SE1 7EH
Novo Nordisk Investigational Site
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01205724     History of Changes
Other Study ID Numbers: NN7088-3776
2010-018520-68 ( EudraCT Number )
U1111-1116-2043 ( Other Identifier: WHO )
JapicCTI-101293 ( Other Identifier: JAPIC )
Study First Received: September 17, 2010
Last Updated: February 9, 2017

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants

ClinicalTrials.gov processed this record on May 23, 2017