Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00486278
First received: June 13, 2007
Last updated: June 10, 2013
Last verified: June 2013

June 13, 2007
June 10, 2013
June 2007
June 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Adverse events: Non-serious adverse events occurring from the first administration of trial product [ Time Frame: Until 7 days after first trial product administration. ]
  • Adverse events: Serious adverse events are collected from the first administration of trial product [ Time Frame: To the end of subjects' participation in the trial ]
Complete list of historical versions of study NCT00486278 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pharmacokinetic parameters
  • Coagulation related parameters
  • Cessation of bleeding
Not Provided
Not Provided
 
Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
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

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 (vatreptacog alfa (activated)) in haemophilia patients with inhibitors.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B
  • Drug: activated recombinant human factor VII
    90 mcg/kg, injected i.v.
  • Drug: vatreptacog alfa (activated)
    5 mcg/kg, injected i.v.
  • Drug: vatreptacog alfa (activated)
    10 mcg/kg, injected i.v.
  • Drug: vatreptacog alfa (activated)
    20 mcg/kg, injected i.v.
  • Drug: vatreptacog alfa (activated)
    40 mcg/kg, injected i.v.
  • Drug: vatreptacog alfa (activated)
    80 mcg/kg, injected i.v.
  • Experimental: A
    Intervention: Drug: vatreptacog alfa (activated)
  • Experimental: B
    Intervention: Drug: vatreptacog alfa (activated)
  • Experimental: C
    Intervention: Drug: vatreptacog alfa (activated)
  • Experimental: D
    Intervention: Drug: vatreptacog alfa (activated)
  • Experimental: E
    Intervention: Drug: vatreptacog alfa (activated)
  • Active Comparator: F
    Intervention: Drug: activated recombinant human factor VII
de Paula EV, Kavakli K, Mahlangu J, Ayob Y, Lentz SR, Morfini M, Nemes L, Šalek SZ, Shima M, Windyga J, Ehrenforth S, Chuansumrit A; 1804 (adept(TM)1) Investigators. Recombinant factor VIIa analog (vatreptacog alfa [activated]) for treatment of joint bleeds in hemophilia patients with inhibitors: a randomized controlled trial. J Thromb Haemost. 2012 Jan;10(1):81-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Male
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Croatia,   Hungary,   Israel,   Italy,   Japan,   Malaysia,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT00486278
NN1731-1804, 2006-004879-35, CTI-080612
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Silke Ehrenforth Novo Nordisk A/S
Novo Nordisk A/S
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP