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Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients (paradigm™ 2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01333111
First received: April 8, 2011
Last updated: January 19, 2017
Last verified: January 2017
  Purpose
This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.

Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia B
Drug: nonacog beta pegol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of inhibitory antibodies against factor IX defined as titre equal to or above 0.6 BU (Bethesda Units) [ Time Frame: 52 weeks after treatment start for patients on prophylaxis ]
  • Incidence of inhibitory antibodies against factor IX defined as titre equal to or above 0.6 BU (Bethesda Units) [ Time Frame: 28 weeks after treatment start on on-demand treatment ]

Secondary Outcome Measures:
  • Haemostatic effect of NNC-0156-0000-0009 when used for prophylaxis of bleeding episodes, assessed as success/failure based on a four-point scale for haemostatic response [ Time Frame: 52 weeks after treatment start for patients on prophylaxis ]
  • Haemostatic effect of NNC-0156-0000-0009 when used for treatment of bleeding episodes, assessed as success/failure based on a four-point scale for haemostatic response [ Time Frame: 28 weeks after treatment start on on-demand treatment ]
  • Number of bleeding episodes per patient during routine prophylaxis [ Time Frame: 52 weeks after treatment start for patients on prophylaxis ]
  • Factor IX trough levels [ Time Frame: 52 weeks after treatment start for patients on prophylaxis ]
  • Incidence of adverse events (AEs) [ Time Frame: at 56 weeks ±2 weeks for patients on prophylaxis ]
  • Incidence of adverse events (AEs) [ Time Frame: at 32 weeks ±2 weeks for patients on on-demand treatment ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: at 56 weeks ±2 weeks for patients on prophylaxis ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: at 32 weeks ±2 weeks for patients on on-demand treatment ]
  • Host Cell Proteins (HCP) antibodies [ Time Frame: 52 weeks after treatment start for patients on prophylaxis ]
  • Host Cell Proteins (HCP) antibodies [ Time Frame: 28 weeks after treatment start on on-demand treatment ]

Enrollment: 74
Study Start Date: April 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylaxis, high dose (trial duration 52 weeks) Drug: nonacog beta pegol
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience
Other Name: NNC-0156-0000-0009
Experimental: Prophylaxis, low dose (trial duration 52 weeks) Drug: nonacog beta pegol
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience
Other Name: NNC-0156-0000-0009
Experimental: On-demand (trial duration 28 weeks) Drug: nonacog beta pegol
Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode
Other Name: NNC-0156-0000-0009

  Eligibility

Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records
  • History of at least 150 exposure days to other factor IX products
  • Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis

Exclusion Criteria:

  • Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews
  • HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL
  • Congenital or acquired coagulation disorders other than haemophilia B
  • Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
  • Immune modulating or chemotherapeutic medication
  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: NCT01333111

  Show 43 Study Locations
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: NCT01333111     History of Changes
Other Study ID Numbers: NN7999-3747
2010-023069-24 ( EudraCT Number )
U1111-1119-6415 ( Other Identifier: WHO )
JapicCTI-111644 ( Other Identifier: Japic )
Study First Received: April 8, 2011
Last Updated: January 19, 2017

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

ClinicalTrials.gov processed this record on April 28, 2017