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Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A (pathfinder™2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01480180
First received: November 23, 2011
Last updated: July 22, 2014
Last verified: July 2014

November 23, 2011
July 22, 2014
January 2012
December 2018   (final data collection date for primary outcome measure)
  • The Incidence rate of FVIII-inhibitors greater than or equal to 0.6 BU (Bethesda Unit) [ Time Frame: The endpoints will be analysed based on all available information after approximately 24 and 36 months and until the end of trial (EOT) visit ] [ Designated as safety issue: No ]
  • Annualised bleeding rate in the prophylaxis arm [ Time Frame: The endpoints will be analysed based on all available information after approximately 24 and 36 months and until the end of trial (EOT) visit ] [ Designated as safety issue: No ]
  • The Incidence rate of FVIII-inhibitors greater than or equal to 0.6 BU (Bethesda Unit) [ Time Frame: The endpoint will be analysed based on all available information until the end of trial (EOT) visit (week 76) and up to approximately 19 months ] [ Designated as safety issue: No ]
  • Annualised bleeding rate in the prophylaxis arm [ Time Frame: The endpoint will be analysed based on all available information until the end of trial (EOT) visit (week 76) and up to approximately 19 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01480180 on ClinicalTrials.gov Archive Site
Haemostatic effect of N8-GP when used for treatment of bleeds, assessed on a four-point scale (excellent, good, moderate and none) [ Time Frame: The endpoints will be analysed based on all available information until the end of trial (EOT) visit and up to approximately 24 and 36 months ] [ Designated as safety issue: No ]
Haemostatic effect of N8-GP when used for treatment of bleeds, assessed on a four-point scale (excellent, good, moderate and none) [ Time Frame: The endpoint will be analysed based on all available information until the end of trial (EOT) visit (week 76) and up to approximately 19 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A
A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A

This trial is conducted globally. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia A
Drug: NNC 0129-0000-1003
Administered i.v.
  • Experimental: Prophylaxis
    Intervention: Drug: NNC 0129-0000-1003
  • Experimental: On-demand
    Intervention: Drug: NNC 0129-0000-1003
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
186
December 2018
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male patients with severe congenital haemophilia A (FVIII activity below 1%, according to medical records)
  • Documented history of at least 150 EDs (exposure days) to other FVIII products
  • At least 12 years and body weight at least 35 kg (except for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be 18 years)

Exclusion Criteria:

  • Previous participation in this trial defined as withdrawal after administration N8-GP
  • Any history of FVIII inhibitors
  • FVIII inhibitors above or equal to 0.6 BU/mL at screening
  • HIV (human immunodeficiency virus) positive, defined by medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral load of more than 400000 copies/mL. If the data is not available in medical records within last 6 months, CD4+ will be measured at the screening visit
  • Congenital or acquired coagulation disorders other than haemophilia A
  • Previous significant thromboembolic events (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined by available medical records
  • Platelet count below 50,000 platelets/mcL (laboratory value at the screening visit)
  • ALAT (alanine aminotransferase) above 3 times the upper limit of normal reference ranges at central laboratory
  • Creatinine level equal to or greater than 1.5 times above upper normal limit (according to central laboratory reference ranges)
  • Ongoing immune modulating or chemotherapeutic medication
Male
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Croatia,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Netherlands,   Norway,   Russian Federation,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom
 
NCT01480180
NN7088-3859, U1111-1119-7416, 2011-001142-15, JapicCTI-121749
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
July 2014

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