Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00956345
First received: August 10, 2009
Last updated: July 4, 2012
Last verified: June 2012
  Purpose

This trial is conducted in Europe, Japan and the United States of America (USA).

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 Pegylated Recombinant Factor IX in Non-Bleeding Patients with Haemophilia B.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia B
Drug: 40K PEG-rFIX
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-Centre, Multi-National, Open-Label, Dose Escalation Trial Evaluating Safety and Pharmacokinetics of Ascending Intravenous Doses of 40K Pegylated Recombinant FIX in Non-Bleeding Patients With Haemophilia B.

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interests (MESIs) reported during the trial period [ Time Frame: assessed up to five weeks after trial product administration ] [ Designated as safety issue: Yes ]
  • Antibody formation against 40K PEG-rFIX and test for inhibitors (Bethesda) [ Time Frame: assessed up to five weeks after trial product administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AUC, CL, T½, Incremental recovery (first sample) from 0 to 48 hours after trial product administration [ Time Frame: assessed up to five weeks after trial product administration ] [ Designated as safety issue: No ]
  • AUC, CL, T½, Incremental recovery (first sample) from 0 to 168 hours after trial product administration [ Time Frame: assessed up to five weeks after trial product administration ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: August 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: 40K PEG-rFIX
Cohort to receive a single dose of 25U/kg 40K PEG-rFIX administered intravenously (into the vein)
Experimental: B Drug: 40K PEG-rFIX
Cohort to receive a single dose of 50U/kg 40K PEG-rFIX administered intravenously (into the vein)
Experimental: C Drug: 40K PEG-rFIX
Cohort to receive a single dose of 100U/kg 40K PEG-rFIX 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:

  • Diagnosed with haemophilia B (baseline level of Factor IX less than or equal to 2%)
  • History of at least 150 exposure days to any Factor IX products
  • Body Mass Index (BMI) below 30.0 kg/m2 (inclusive)

Exclusion Criteria:

  • History of Factor IX inhibitors
  • Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
  • Kidney or liver dysfunction
  • Scheduled surgery requiring Factor IX replacement therapy, during the trial period
  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: NCT00956345

Locations
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97239
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23219
France
Lyon, France, 69003
Germany
Berlin, Germany, 10249
Japan
Kashihara-shi, Nara, Japan, 634 8522
Spain
Madrid, Spain, 28046
United Kingdom
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Karin Knobe, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00956345     History of Changes
Other Study ID Numbers: NN7999-3639, 2009-011085-28, 090857
Study First Received: August 10, 2009
Last Updated: July 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut
Spain: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Japan: Ministry of Health, Labor and Welfare
United States: Food and Drug Administration

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemophilia B
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014