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Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00486278
First received: June 13, 2007
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

This trial is conducted in Africa, Asia, Europe, Japan, and North and South America.

The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue in haemophilia patients with inhibitors.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
 Drug: activated recombinant human factor VII
Drug: activated recombinant human factor VII analogue
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Double-blinded, Controlled, Dose-escalation Trial on Safety and Efficacy of Activated Recombinant FVII Analogue (NN1731) in the Treatment of Joint Bleeds in Congenital Haemophilia Patients With Inhibitors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Adverse events: Non-serious adverse events occurring from the first administration of trial product [ Time Frame: until 7 days after first trial product administration. ] [ Designated as safety issue: Yes ]
  • Serious adverse events are collected form the first trial product administration of trial product [ Time Frame: to the end of subjects participation (up to maximum 24 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameter: Activated recombinant human factor VII analogue activity in the blood (IU/ml) [ Time Frame: 0-24 hours after trial product administration ] [ Designated as safety issue: No ]
  • Coagulation related parameter- Prothrombin Time (PT) [ Time Frame: predose- 24 hours after trial product administration ] [ Designated as safety issue: No ]
  • Coagulation related parameter: F1 + 2 (Prothrombin Fragments 1+2) [ Time Frame: predose- 24 hours after trial product administration ] [ Designated as safety issue: No ]
  • Coagulation related parameter- activated Partial Thromboplastin Time (aPTT) [ Time Frame: Predose- 24 hours after trial product administration ] [ Designated as safety issue: No ]
  • Cessation of bleeding: Number of doses needed to control bleeding. Need evaluated after each of 1-3 doses [ Time Frame: Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure) ] [ Designated as safety issue: No ]
  • Need for additional haemostatic agents [ Time Frame: within 24 hours after succesful control of bleeding episode with trial product ] [ Designated as safety issue: No ]
  • Pharmakokinetic parameters based on FVlla activity: AUC 0-t (Area under the plasma FVIIa activity-time curve from time zero to the time (t) ) and AUC (Area under the plasma FVIIa activity-time curve from time zero to infinity) [ Time Frame: 0-24 hours after trial product administration ] [ Designated as safety issue: No ]
  • Pharmakokinetic parameters based on FVlla activity: MRT (Mean residence time) [ Time Frame: 0-24 hours after trial product administration ] [ Designated as safety issue: No ]
  • Pharmakokinetic parameters based on FVlla activity: t½ (Terminal half-life) [ Time Frame: 0-24 hours after trial product administration ] [ Designated as safety issue: No ]
  • Pharmakokinetic parameters based on FVlla activity: CL (Total clearance) [ Time Frame: 0-24 hours after trial product administration ] [ Designated as safety issue: No ]
  • Pharmakokinetic parameters based on FVlla activity: Vss (Distribution volume at steady state) [ Time Frame: 0-24 hours after trial product administration ] [ Designated as safety issue: No ]
  • Immunogenicity (inhibitor development) [ Time Frame: screening visit, predose, 7 days after dosing and 28 after dosing ] [ Designated as safety issue: No ]
  • Biocemistry: ALAT (Alanine aminotransferase) [ Time Frame: screening visit, predose and 12 hours after dosing ] [ Designated as safety issue: No ]
  • Biocemestry: Creatine [ Time Frame: screening visit, predose and 12 hours after dosing ] [ Designated as safety issue: No ]
  • Haematology: Haemoglobin (g/dL) [ Time Frame: screening visit, predose and 12 hours after dosing ] [ Designated as safety issue: No ]
  • Haematology: Red cell count (x 10^12/L) [ Time Frame: screening visit, predose and 12 hours after dosing ] [ Designated as safety issue: No ]
  • Haematology: Packed cell volume (%) [ Time Frame: screening visit, predose and 12 hours after dosing ] [ Designated as safety issue: No ]
  • Haematology: White cell count (x 10^9/L) [ Time Frame: screening visit, predose and 12 hours after dosing ] [ Designated as safety issue: No ]
  • Haematology: Platelet count (x 10^9/L) [ Time Frame: screening visit, predose and 12 hours after dosing ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: June 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: activated recombinant human factor VII analogue
5 mcg/kg, injected i.v.
Experimental: B Drug: activated recombinant human factor VII analogue
10 mcg/kg, injected i.v.
Experimental: C Drug: activated recombinant human factor VII analogue
20 mcg/kg, injected i.v.
Experimental: D Drug: activated recombinant human factor VII analogue
40 mcg/kg, injected i.v.
Experimental: E Drug: activated recombinant human factor VII analogue
80 mcg/kg, injected i.v.
Active Comparator: F Drug: activated recombinant human factor VII
90 mcg/kg, injected i.v.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Congenital haemophilia patients with inhibitors
  • Age eligible for trial participation: 12 years and above. For Croatia, France and United Kingdom: 18 years and above.
  • Haemophilia patients with high bleeding frequency
  • Historical peak inhibitor titre of at least 5 Bethesda Units

Exclusion Criteria:

  • Known active pseudo tumours
  • Platelet count lower than 50,000 mm^3
  • Severe liver disease
  • Known allergy to trial product(s) or related products
  • Recent surgery
  • Any history of thromboembolic events
  • Advanced atherosclerotic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486278

  Show 22 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Silke Ehrenforth Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00486278     History of Changes
Other Study ID Numbers: NN1731-1804, 2006-004879-35, CTI-080612
Study First Received: June 13, 2007
Last Updated: July 9, 2012
Health Authority: Turkey: Ministry of Health Drug and Pharmaceutical Department
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Canada: Health Canada
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
South Africa: Medicines Control Council
Spain: Spanish Drug Agency and Medicinal Products
United Kingdom: Medicines and Healthcare Products Regulatory
United States: Food and Drug Administration
Japan: Ministry of Health, Labour and Welfare (MHLW)
Croatia: Ministry of Health and Social Care
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health
Malaysia: Drug Control Authority (DCA)
Poland: The Office for Reg. of Medicinal Products, Medical Devices and Biocidal Products - Central Register of Clinical Trials
Taiwan: Department of Health
Thailand: Ministry of Public Health

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

ClinicalTrials.gov processed this record on May 19, 2013